MedPath
FDA Approval

Armour Thyroid

September 22, 2023

HUMAN PRESCRIPTION DRUG LABEL

Thyroid, porcine(60 mg in 1 1)

Registrants (1)

PD-Rx Pharmaceuticals, Inc.

156893695

Manufacturing Establishments (1)

PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc.

156893695

Products (1)

Armour Thyroid

55289-261

ORAL

September 22, 2023

CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
DEXTROSEInactive
Code: IY9XDZ35W2Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Code: 6RV024OAUQClass: ACTIBQuantity: 60 mg in 1 1

Drug Labeling Information

DESCRIPTION SECTION

DESCRIPTION

Armour ® Thyroid (thyroid tablets, USP)* for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. (T 3 liothyronine is approximately four times as potent as T 4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose, microcrystalline cellulose, sodium starch glycolate and opadry white.

STRUCTURAL FORMULAS

Structural Formulas


HOW SUPPLIED SECTION

HOW SUPPLIED

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

60 mg (1 grain) are available in bottles of 30 (NDC 55289-261-30) and bottles of 90 (NDC 55289-261-90).

Armour ® Thyroid (thyroid tablets, USP) is evenly colored, light tan, round tablets, with convex surfaces. One side is 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

1 grain

TE

Note: (T 3 liothyronine is approximately four times as potent as T 4 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.

ARMOUR ® is a registered trademark of Allergan Sales, LLC
Allergan® and its design are trademarks of Allergan, Inc.

Revised: June 2018

v.1.0USPI0457


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