Registrants (1)
156893695
Manufacturing Establishments (1)
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
Products (1)
Armour Thyroid
55289-261
ORAL
September 22, 2023
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 |
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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