SPL v1
SPL
SPL Set ID 3c2688e4-e703-4213-e063-6394a90a7057
Route
ORAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Liothyronine (2.25 ug) Levothyroxine (9.5 ug)
Inactive Ingredients
Dextrose Monohydrate Calcium Stearate Maltodextrin Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: AP;327 Shape: round Color: brown Size: 6 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-08-01

Description

Take 1 tablet daily on an empty stomach or as directed.


Medication Information

Warnings and Precautions

Do not exceed recommended dose. Keep out of reach of children.

Indications and Usage

Used as a thyroid hormone replacement for hypothyroidism.

Dosage and Administration

Take 1 tablet daily on an empty stomach or as directed.

Description

Take 1 tablet daily on an empty stomach or as directed.

Section 50565-1

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Section 51727-6

Calcium stearate, dextrose, maltodextrin, mineral oil, modified wheat starch

Section 55105-1

Thyroid hormone replacement

Section 55106-9

Thyroid 15 mg

17224 511 30

Package label for NP Thyroid 15 mg tablets (30 tablets per bottle). Contains product name, dosage strength, NDC 17224-511-30, manufacturer/repacker name, and usage instructions as printed on the label.


Structured Label Content

Indications and Usage (34067-9)

Used as a thyroid hormone replacement for hypothyroidism.

Dosage and Administration (34068-7)

Take 1 tablet daily on an empty stomach or as directed.

Warnings and Precautions (34071-1)

Do not exceed recommended dose. Keep out of reach of children.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Section 51727-6 (51727-6)

Calcium stearate, dextrose, maltodextrin, mineral oil, modified wheat starch

Section 55105-1 (55105-1)

Thyroid hormone replacement

Section 55106-9 (55106-9)

Thyroid 15 mg

17224 511 30 (17224-511-30)

Package label for NP Thyroid 15 mg tablets (30 tablets per bottle). Contains product name, dosage strength, NDC 17224-511-30, manufacturer/repacker name, and usage instructions as printed on the label.


Advanced Ingredient Data


Raw Label Data

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