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Armour Thyroid - Pakningsvedlegg

ARMOUR THYROID- thyroid, porcine tablet

Allergan, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this

labeling has not been approved by FDA.

----------

Armour Thyroid

(thyroid tablets, USP)

Rx only


DESCRIPTION

Armour Thyroid (thyroid tablets, USP)* for oral use is a desiccated thyroid extract that is

derived from porcine thyroid glands. (T3 liothyronine is approximately four times as

potent as T4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg

levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive

ingredients are calcium stearate, dextrose, microcrystalline cellulose, sodium starch

glycolate and opadry white. Armour Thyroid may have a strong, characteristic odor due

to its thyroid extract component.





CLINICAL PHARMACOLOGY

The steps in the synthesis of the thyroid hormones are controlled by thyrotropin

(Thyroid Stimulating Hormone, TSH) secreted by the anterior pituitary. This hormone’s

secretion is in turn controlled by a feedback mechanism effected by the thyroid

hormones themselves and by thyrotropin releasing hormone (TRH), a tripeptide of

hypothalamic origin. Endogenous thyroid hormone secretion is suppressed when

exogenous thyroid hormones are administered to euthyroid individuals in excess of the

normal gland’s secretion.


The mechanisms by which thyroid hormones exert their physiologic action are not well

understood. These hormones enhance oxygen consumption by most tissues of the

body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids,

and proteins. Thus, they exert a profound influence on every organ system in the body

and are of particular importance in the development of the central nervous system.


The normal thyroid gland contains approximately 200 mcg of levothyroxine (T4) per

gram of gland, and 15 mcg of liothyronine (T3) per gram. The ratio of these two

hormones in the circulation does not represent the ratio in the thyroid gland, since

about 80% of peripheral liothyronine (T3) comes from monodeiodination of

levothyroxine (T4). Peripheral monodeiodination of levothyroxine (T4) at the 5 position

(inner ring) also results in the formation of reverse liothyronine (T3), which is

calorigenically inactive.


Liothyronine (T3) levels are low in the fetus and newborn, in old age, in chronic caloric

deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses

representing what has been called the “T3 thyronine syndrome.”


Pharmacokinetics –

Animal studies have shown that levothyroxine (T4) is only partially absorbed from the

gastrointestinal tract. The degree of absorption is dependent on the vehicle used for its

administration and by the character of the intestinal contents, the intestinal flora,

including plasma protein, and soluble dietary factors, all of which bind thyroid and

thereby make it unavailable for diffusion. Only 41% is absorbed when given in a gelatin

capsule as opposed to a 74% absorption when given with an albumin carrier.


Depending on other factors, absorption has varied from 48 to 79% of the administered

dose. Fasting increases absorption. Malabsorption syndromes, as well as dietary

factors, (children’s soybean formula, concomitant use of anionic exchange resins such

as cholestyramine) cause excessive fecal loss. Liothyronine (T3) is almost totally

absorbed, 95% in 4 hours. The hormones contained in desiccated thyroid extract

preparations are absorbed in a manner similar to the synthetic hormones.


More than 99% of circulating hormones are bound to serum proteins, including thyroid-

binding globulin (TBg), thyroid-binding prealbumin (TBPA), and albumin (TBa), whose

capacities and affinities vary for the hormones. The higher affinity of levothyroxine (T4)

for both TBg and TBPA as compared to liothyronine (T3) partially explains the higher

serum levels and longer half-life of the former hormone. Both protein-bound hormones

exist in reverse equilibrium with minute amounts of free hormone, the latter accounting

for the metabolic activity.


Deiodination of levothyroxine (T4) occurs at a number of sites, including liver, kidney,

and other tissues. The conjugated hormone, in the form of glucuronide or sulfate, is

found in the bile and gut where it may complete an enterohepatic circulation. 85% of

levothyroxine (T4) metabolized daily is deiodinated.


INDICATIONS AND USAGE

Armour Thyroid (thyroid tablets, USP) are indicated:

1. As replacement or supplemental therapy in patients with hypothyroidism of any

etiology, except transient hypothyroidism during the recovery phase of subacute

thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in

patients of any age (children, adults, the elderly), or state (including pregnancy); primary

hypothyroidism resulting from functional deficiency, primary atrophy, partial or total

absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without

the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic)

hypothyroidism (See WARNINGS).

2. As pituitary TSH suppressants, in the treatment or prevention of various types of

euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis

(Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.


CONTRAINDICATIONS

Thyroid hormone preparations are generally contraindicated in patients with diagnosed

but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and

apparent hypersensitivity to any of their active or extraneous constituents. There is no

well-documented evidence from the literature, however, of true allergic or idiosyncratic

reactions to thyroid hormone.


WARNINGS

Drugs with thyroid hormone activity, alone or together with other

therapeutic agents, have been used for the treatment of obesity. In

euthyroid patients, doses within the range of daily hormonal

requirements are ineffective for weight reduction. Larger doses may

produce serious or even life-threatening manifestations of toxicity,

particularly when given in association with sympathomimetic amines

such as those used for their anorectic effects.


The use of thyroid hormones in the therapy of obesity, alone or combined with other

drugs, is unjustified and has been shown to be ineffective. Neither is their use justified

for the treatment of male or female infertility unless this condition is accompanied by

hypothyroidism.


The active ingredient in Armour Thyroid (thyroid tablets, USP) is derived from porcine

(pig) thyroid glands of pigs processed for human food consumption and is produced at

a facility that also handles bovine (cow) tissues from animals processed for human food

consumption. As a result, a potential risk of product contamination with porcine and

bovine viral or other adventitious agents cannot be ruled out. No cases of disease

transmission associated with the use of Armour Thyroid (thyroid tablets, USP) have

been reported.


PRECAUTIONS

General —

Thyroid hormones should be used with great caution in a number of circumstances

where the integrity of the cardiovascular system, particularly the coronary arteries, is

suspected. These include patients with angina pectoris or the elderly, in whom there is a

greater likelihood of occult cardiac disease. In these patients, therapy should be initiated

with low doses, i.e., 15-30 mg Armour Thyroid (thyroid tablets, USP). When, in such

patients, a euthyroid state can only be reached at the expense of an aggravation of the

cardiovascular disease, thyroid hormone dosage should be reduced.


Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes

insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms.

Appropriate adjustments of the various therapeutic measures directed at these

concomitant endocrine diseases are required. The therapy of myxedema coma requires

simultaneous administration of glucocorticoids (See DOSAGE AND ADMINISTRATION).


Hypothyroidism decreases and hyperthyroidism increases the sensitivity to oral

anticoagulants. Prothrombin time should be closely monitored in thyroid-treated patients

on oral anticoagulants and dosage of the latter agents adjusted on the basis of frequent

prothrombin time determinations. In infants, excessive doses of thyroid hormone

preparations may produce craniosynostosis.


Information for the Patient —

Patients on thyroid hormone preparations and parents of children on thyroid therapy

should be informed that:

1. Replacement therapy is to be taken essentially for life, with the exception of cases of

transient hypothyroidism, usually associated with thyroiditis, and in those patients

receiving a therapeutic trial of the drug.

2. They should immediately report during the course of therapy any signs or symptoms

of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations,

excessive sweating, heat intolerance, nervousness, or any other unusual event.

3. In case of concomitant diabetes mellitus, the daily dosage of antidiabetic medication

may need readjustment as thyroid hormone replacement is achieved. If thyroid

medication is stopped, a downward readjustment of the dosage of insulin or oral

hypoglycemic agent may be necessary to avoid hypoglycemia. At all times, close

monitoring of urinary glucose levels is mandatory in such patients.

4. In case of concomitant oral anticoagulant therapy, the prothrombin time should be

measured frequently to determine if the dosage of oral anticoagulants is to be

readjusted.

5. Instruct patients to discontinue biotin or any biotin-containing supplements for at

least 2 days before thyroid function testing is conducted.

6. Partial loss of hair may be experienced by children in the first few months of thyroid

therapy, but this is usually a transient phenomenon and later recovery is usually the rule.


Laboratory Tests —

Treatment of patients with thyroid hormones requires the periodic assessment of

thyroid status by means of appropriate laboratory tests besides the full clinical

evaluation. The TSH suppression test can be used to test the effectiveness of any

thyroid preparation bearing in mind the relative insensitivity of the infant pituitary to the

negative feedback effect of thyroid hormones. Serum T4 levels can be used to test the

effectiveness of all thyroid medications except T3. When the total serum T4 is low but

TSH is normal, a test specific to assess unbound (free) T4 levels is warranted. Specific

measurements of T4 and T3 by competitive protein binding or radioimmunoassay are

not influenced by blood levels of organic or inorganic iodine.


Drug Interactions —

Oral Anticoagulants – Thyroid hormones appear to increase catabolism of vitamin K-

dependent clotting factors. If oral anticoagulants are also being given, compensatory

increases in clotting factor synthesis are impaired. Patients stabilized on oral

anticoagulants who are found to require thyroid replacement therapy should be watched

very closely when thyroid is started. If a patient is truly hypothyroid, it is likely that a

reduction in anticoagulant dosage will be required. No special precautions appear to be

necessary when oral anticoagulant therapy is begun in a patient already stabilized on

maintenance thyroid replacement therapy.


Insulin or Oral Hypoglycemics – Initiating thyroid replacement therapy may cause

increases in insulin or oral hypoglycemic requirements. The effects seen are poorly

understood and depend upon a variety of factors such as dose and type of thyroid

preparations and endocrine status of the patient. Patients receiving insulin or oral

hypoglycemics should be closely watched during initiation of thyroid replacement

therapy.


Cholestyramine or Colestipol – Cholestyramine or colestipol binds both levothyroxine

(T4) and liothyronine (T3) in the intestine, thus impairing absorption of these thyroid

hormones. In vitro studies indicate that the binding is not easily removed. Therefore four

to five hours should elapse between administration of cholestyramine or colestipol and

thyroid hormones.


Estrogen, Oral Contraceptives – Estrogens tend to increase serum thyroxine-binding

globulin (TBg). In a patient with a nonfunctioning thyroid gland who is receiving thyroid

replacement therapy, free levothyroxine (T4) may be decreased when estrogens are

started thus increasing thyroid requirements. However, if the patient’s thyroid gland has

sufficient function, the decreased free levothyroxine (T4) will result in a compensatory

increase in levothyroxine (T4) output by the thyroid. Therefore, patients without a

functioning thyroid gland who are on thyroid replacement therapy may need to increase

their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.


Drug/Laboratory Test Interactions —

The following drugs or moieties are known to interfere with laboratory tests performed

in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral

contraceptives containing estrogens, iodine-containing preparations, and the numerous

preparations containing salicylates.

1. Changes in TBg concentration should be taken into consideration in the interpretation

of levothyroxine (T4) and liothyronine (T3) values. In such cases, the unbound (free)

hormone should be measured. Pregnancy, estrogens, and estrogen-containing oral

contraceptives increase TBg concentrations. TBg may also be increased during

infectious hepatitis. Decreases in TBg concentrations are observed in nephrosis,

acromegaly, and after androgen or corticosteroid therapy. Familial hyper- or hypo-

thyroxine-binding-globulinemias have been described. The incidence of TBg deficiency

approximates 1 in 9000. The binding of levothyroxine by TBPA is inhibited by salicylates.

2. Biotin supplementation is known to interfere with thyroid hormone immunoassays

that are based on a biotin and streptavidin interaction, which may result in erroneous

thyroid hormone test results. Stop biotin and biotin-containing supplements for at least

2 days prior to thyroid testing.

3. Medicinal or dietary iodine interferes with all in vivo tests of radio-iodine uptake,

producing low uptakes which may not be relative of a true decrease in hormone

synthesis.

4. The persistence of clinical and laboratory evidence of hypothyroidism in spite of

adequate dosage replacement indicates either poor patient compliance, poor absorption,

excessive fecal loss, or inactivity of the preparation. Intracellular resistance to thyroid

hormone is quite rare.


Carcinogenesis, Mutagenesis, and Impairment of Fertility —

A reportedly apparent association between prolonged thyroid therapy and breast cancer

has not been confirmed and patients on thyroid for established indications should not

discontinue therapy. No confirmatory long-term studies in animals have been performed

to evaluate carcinogenic potential, mutagenicity, or impairment of fertility in either males

or females.


Thyroid hormones do not readily cross the placental barrier. The clinical experience to

date does not indicate any adverse effect on fetuses when thyroid hormones are

administered to pregnant women. On the basis of current knowledge, thyroid

replacement therapy to hypothyroid women should not be discontinued during

pregnancy.


Nursing Mothers —

Minimal amounts of thyroid hormones are excreted in human milk. Thyroid is not

associated with serious adverse reactions and does not have a known tumorigenic

potential. However, caution should be exercised when thyroid is administered to a

nursing woman.


Pediatric Use —

Pregnant mothers provide little or no thyroid hormone to the fetus. The incidence of

congenital hypothyroidism is relatively high (1:4,000) and the hypothyroid fetus would

not derive any benefit from the small amounts of hormone crossing the placental

barrier. Routine determinations of serum T4 and/or TSH is strongly advised in neonates

in view of the deleterious effects of thyroid deficiency on growth and development.


Treatment should be initiated immediately upon diagnosis, and maintained for life, unless

transient hypothyroidism is suspected; in which case, therapy may be interrupted for 2

to 8 weeks after the age of 3 years to reassess the condition. Cessation of therapy is

justified in patients who have maintained a normal TSH during those 2 to 8 weeks.


ADVERSE REACTIONS

Adverse reactions other than those indicative of hyperthyroidism because of therapeutic

overdosage, either initially or during the maintenance period, are rare (See

OVERDOSAGE).


OVERDOSAGE

Signs and Symptoms —

Excessive doses of thyroid result in a hypermetabolic state resembling in every respect

the condition of endogenous origin. The condition may be self-induced.


Treatment of Overdosage —

Dosage should be reduced or therapy temporarily discontinued if signs and symptoms

of overdosage appear.

Treatment may be reinstituted at a lower dosage. In normal individuals, normal

hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid

suppression.


Treatment of acute massive thyroid hormone overdosage is aimed at reducing

gastrointestinal absorption of the drugs and counteracting central and peripheral

effects, mainly those of increased sympathetic activity. Vomiting may be induced initially

if further gastrointestinal absorption can reasonably be prevented and barring

contraindications such as coma, convulsions, or loss of the gagging reflex. Treatment is

symptomatic and supportive. Oxygen may be administered and ventilation maintained.


Cardiac glycosides may be indicated if congestive heart failure develops. Measures to

control fever, hypoglycemia, or fluid loss should be instituted if needed. Antiadrenergic

agents, particularly propranolol, have been used advantageously in the treatment of

increased sympathetic activity. Propranolol may be administered intravenously at a

dosage of 1 to 3 mg, over a 10-minute period or orally, 80 to 160 mg/day, initially,

especially when no contraindications exist for its use.


Other adjunctive measures may include administration of cholestyramine to interfere

with thyroxine absorption, and glucocorticoids to inhibit conversion of T4 to T3.


DOSAGE AND ADMINISTRATION

The dosage of thyroid hormones is determined by the indication and must in every case

be individualized according to patient response and laboratory findings.

Biotin supplementation may interfere with immunoassays for TSH, T4, and T3, resulting

in erroneous thyroid hormone test results. Inquire whether patients are taking biotin or

biotin-containing supplements. If so, advise them to stop biotin supplementation at least

2 days before assessing TSH and/or T4 levels (see PRECAUTIONS).

Thyroid hormones are given orally. In acute, emergency conditions, injectable

levothyroxine sodium (T4) may be given intravenously when oral administration is not

feasible or desirable, as in the treatment of myxedema coma, or during total parenteral

nutrition. Intramuscular administration is not advisable because of reported poor

absorption.


Hypothyroidism —

Therapy is usually instituted using low doses, with increments which depend on the

cardiovascular status of the patient. The usual starting dose is 30 mg Armour Thyroid

(thyroid tablets, USP), with increments of 15 mg every 2 to 3 weeks. A lower starting

dosage, 15 mg/day, is recommended in patients with long-standing myxedema,

particularly if cardiovascular impairment is suspected, in which case extreme caution is

recommended. The appearance of angina is an indication for a reduction in dosage.


Most patients require 60 to 120 mg/day. Failure to respond to doses of 180 mg

suggests lack of compliance or malabsorption. Maintenance dosages 60 to 120 mg/day

usually result in normal serum T4 and T3 levels. Adequate therapy usually results in

normal TSH and T4 levels after 2 to 3 weeks of therapy.

Readjustment of thyroid hormone dosage should be made within the first four weeks of

therapy, after proper clinical and laboratory evaluations, including serum levels of T4,

bound and free, and TSH.


Liothyronine (T3) may be used in preference to levothyroxine (T4) during radio-isotope

scanning procedures, since induction of hypothyroidism in those cases is more abrupt

and can be of shorter duration. It may also be preferred when impairment of peripheral

conversion of levothyroxine (T4) and liothyronine (T3) is suspected.


Myxedema Coma —

Myxedema coma is usually precipitated in the hypothyroid patient of long-standing by

intercurrent illness or drugs such as sedatives and anesthetics and should be

considered a medical emergency. Therapy should be directed at the correction of

electrolyte disturbances and possible infection besides the administration of thyroid

hormones. Corticosteroids should be administered routinely. Levothyroxine (T4) and

liothyronine (T3) may be administered via a nasogastric tube but the preferred route of

administration of both hormones is intravenous. Levothyroxine sodium (T4) is given at a

starting dose of 400 mcg (100 mcg/mL) given rapidly, and is usually well tolerated, even

in the elderly. This initial dose is followed by daily supplements of 100 to 200 mcg given

IV. Normal T4 levels are achieved in 24 hours followed in 3 days by threefold elevation of

T3. Oral therapy with thyroid hormone would be resumed as soon as the clinical

situation has been stabilized and the patient is able to take oral medication.


Thyroid Cancer —

Exogenous thyroid hormone may produce regression of metastases from follicular and

papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions

with radioactive iodine. TSH should be suppressed to low or undetectable levels.

Therefore, larger amounts of thyroid hormone than those used for replacement therapy

are required. Medullary carcinoma of the thyroid is usually unresponsive to this therapy.


Thyroid Suppression Therapy —

Administration of thyroid hormone in doses higher than those produced physiologically

by the gland results in suppression of the production of endogenous hormone. This is

the basis for the thyroid suppression test and is used as an aid in the diagnosis of

patients with signs of mild hyperthyroidism in whom base line laboratory tests appear

normal, or to demonstrate thyroid gland autonomy in patients with Grave’s

ophthalmopathy. 131I uptake is determined before and after the administration of the

exogenous hormone. A 50% or greater suppression of uptake indicates a normal

thyroid-pituitary axis and thus rules out thyroid gland autonomy.


For adults, the usual suppressive dose of levothyroxine (T4) is 1.56 mcg/kg of body

weight per day given for 7 to 10 days. These doses usually yield normal serum T4 and

T3 levels and lack of response to TSH.

Thyroid hormones should be administered cautiously to patients in whom there is strong

suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone

effects will be additive to the endogenous source.


Pediatric Dosage —

Pediatric dosage should follow the recommendations summarized in Table 1. In infants

with congenital hypothyroidism, therapy with full doses should be instituted as soon as

the diagnosis has been made.


Table 1: Recommended Pediatric Dosage for Congenital Hypothyroidism

Age Armour Thyroid (thyroid tablets, USP)

Dose per day Daily dose per kg of body

weight

0-6 months 15-30 mg 4.8-6 mg

6-12 months 30-45 mg 3.6-4.8 mg

1-5 years 45-60 mg 3-3.6 mg

6-12 years 60-90 mg 2.4-3 mg

Over 12 years Over 90 mg 1.2-1.8 mg

HOW SUPPLIED

Armour Thyroid (thyroid tablets, USP) are supplied as follows:

15 mg (1/4 grain) are available in bottles of 100 (NDC 0456-0457-01 or NDC 0456-1045-

01).

30 mg (1/2 grain) are available in bottles of 100 (NDC 0456-0458-01) and unit dose

cartons of 100 (NDC 0456-0458-63).

60 mg (1 grain) are available in bottles of 100 (NDC 0456-0459-01) and unit dose

cartons of 100 (NDC 0456-0459-63).

90 mg (1 1/2 grain) are available in bottles of 100 (NDC 0456-0460-01).

120 mg (2 grain) are available in bottles of 100 (NDC 0456-0461-01) and unit dose

cartons of 100 (NDC 0456-0461-63).

180 mg (3 grain) are available in bottles of 100 (NDC 0456-0462-01).

240 mg (4 grain) are available in bottles of 100 (NDC 0456-0463-01).

300 mg (5 grain) are available in bottles of 100 (NDC 0456-0464-01).

The bottles of 100 are special dispensing bottles with child-resistant closures.


Armour Thyroid (thyroid tablets, USP) are evenly colored, light tan, round tablets, with

convex surfaces.

The ¼ grain strength has:

One side debossed with a mortar and pestle beneath the letter “A” on the top and TC

on the bottom (NDC 0456-0457-01);

or

One side debossed with a mortar and pestle beneath the letter “A” and the opposite

side debossed with TC (NDC 0456-1045-01).

Other tablet strengths have one side debossed with a mortar and pestle beneath the

letter “A” on the top and strength code letters on the bottom as defined below

Strength Code

½ grain TD

1 grain TE

1 ½ grain TJ

2 grain TF

3 grain TG (bisected)

4 grain TH

5 grain TI (bisected)

Note: (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a

microgram for microgram basis.)

Store in a tight container protected from light and moisture. Store between 15°C and

30°C (59°F and 86°F).

*Armour Thyroid (thyroid tablets, USP) has not been approved by FDA as a new drug.

Distributed by:

AbbVie, Inc., North Chicago, IL 60064

© 2024 AbbVie. All rights reserved.

ARMOUR is a trademark of Allergan Sales, LLC, an AbbVie company.

Revised: March 2024 20084309

PRINCIPAL DISPLAY PANEL

NDC 0456-0457-01

Armour Thyroid

(thyroid tablets, USP)

¼ GRAIN (15 mg)

Each tablet contains:

levothyroxine (T ) 9.5 mcg

liothyronine (T ) 2.25 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-0458-01

Armour Thyroid

(thyroid tablets, USP)

½ GRAIN (30 mg)

Each tablet contains:

levothyroxine (T ) 19 mcg

liothyronine (T ) 4.5 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-0459-01

Armour Thyroid

(thyroid tablets, USP)

1 GRAIN (60 mg)

Each tablet contains:

levothyroxine (T ) 38 mcg

liothyronine (T ) 9 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-0460-01

Armour Thyroid

(thyroid tablets, USP)

1½ GRAIN (90 mg)

Each tablet contains:

levothyroxine (T ) 57 mcg

liothyronine (T ) 13.5 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-0461-01

Armour Thyroid

(thyroid tablets, USP)

2 GRAIN (120 mg)

Each tablet contains:

levothyroxine (T ) 76 mcg

liothyronine (T ) 18 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-0462-01

Armour Thyroid

(thyroid tablets, USP)

3 GRAIN (180 mg)

Each tablet contains:

levothyroxine (T ) 114 mcg

liothyronine (T ) 27 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-0463-01

Armour Thyroid

(thyroid tablets, USP)

4 GRAIN (240 mg)

Each tablet contains:

levothyroxine (T ) 152 mcg

liothyronine (T ) 36 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-0464-01

Armour Thyroid

(thyroid tablets, USP)

5 GRAIN (300 mg)

Each tablet contains:

levothyroxine (T ) 190 mcg

liothyronine (T ) 45 mcg

100 TABLETS

abbvie

Rx only

®

4

3

PRINCIPAL DISPLAY PANEL

NDC 0456-1045-01

Armour Thyroid

(thyroid tablets, USP)

1/4 GRAIN (15 mg)

ARMOUR THYROID

®

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0457

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 15 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 5mm

Flavor Imprint Code A;TC

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-0457-

01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-1045

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 15 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 5mm

Flavor Imprint Code A;TC

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-1045-

01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0458

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 30 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 6mm

Flavor Imprint Code A;TD

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-

0458-01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

2 NDC:0456-

0458-63 10 in 1 BOX, UNIT-DOSE 04/01/1996

2 NDC:0456-

0458-11

10 in 1 BLISTER PACK; Type 0: Not a Combination

Product

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0459

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 60 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 7mm

Flavor Imprint Code A;TE

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-

0459-01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

2 NDC:0456-

0459-63 10 in 1 BOX, UNIT-DOSE 04/01/1996

2 NDC:0456-

0459-11

10 in 1 BLISTER PACK; Type 0: Not a Combination

Product

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0460

Route of Administration ORAL

Active Ingredient/Active Moiety

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 90 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 9mm

Flavor Imprint Code A;TJ

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-0460-

01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0461

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 120 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 10mm

Flavor Imprint Code A;TF

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-

0461-01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

2 NDC:0456-

0461-63 10 in 1 BOX, UNIT-DOSE 04/01/1996

2 NDC:0456-

0461-11

10 in 1 BLISTER PACK; Type 0: Not a Combination

Product

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0462

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 180 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 10mm

Flavor Imprint Code A;TG

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-0462-

01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0463

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 240 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 11mm

Flavor Imprint Code A;TH

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-0463-

01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

ARMOUR THYROID

thyroid, porcine tablet

Product Information

Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-0464

Route of Administration ORAL

Active Ingredient/Active Moiety

Ingredient Name Basis of

Strength Strength

SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID -

UNII:6RV024OAUQ)

SUS SCROFA

THYROID 300 mg

Inactive Ingredients

Ingredient Name Strength

CALCIUM STEARATE (UNII: 776XM7047L)

DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ 35W2)

CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Allergan, Inc.

Product Characteristics

Color brown (light tan) Score no s core

Shape ROUND (ROUND) Size 13mm

Flavor Imprint Code A;TI

Contains

Packaging

# Item Code Package Description Marketing Start

Date

Marketing End

Date

1 NDC:0456-0464-

01

100 in 1 BOTTLE; Type 0: Not a Combination

Product 04/01/1996

Marketing Information

Marketing

Category

Application Number or Monograph

Citation

Marketing Start

Date

Marketing End

Date

unapproved drug

other 04/01/1996

Labeler - Allergan, Inc. (144796497)

Revised: 3/2024

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