DailyMed - DailyMed Details

SPL v1

SPL

SPL Set ID 3bf259f5-59b4-de7e-e063-6294a90a4376

Route

ORAL

Published

Effective Date 2025-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Levothyroxine (57 ug) Liothyronine (13.5 ug)

Inactive Ingredients

Maltodextrin Anhydrous Dextrose Calcium Stearate Mineral Oil

Identifiers & Packaging

Pill Appearance

Imprint: AP;331 Shape: round Color: brown Size: 8 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 90 mg

Ndc 17224 504 60

Package label for NP Thyroid 90 mg tablets (60 tablets per bottle). Contains product name, dosage strength,

, 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 90 mg

Ndc 17224 504 60 (NDC 17224-504-60)

Package label for NP Thyroid 90 mg tablets (60 tablets per bottle). Contains product name, dosage strength,

, manufacturer/repacker name, and usage instructions as printed on the label.

Advanced Ingredient Data

[{"name": "LEVOTHYROXINE", "unii": "Q51BO43MG4", "classCode": "ACTIB", "strengthNumerator": "57", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DEXTROSE", "unii": "5SL0G7R0OK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM STEARATE", "unii": "776XM7047L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIOTHYRONINE", "unii": "06LU7C9H1V", "classCode": "ACTIB", "strengthNumerator": "13.5", "strengthDenominator": "1", "strengthNumeratorUnit": "ug", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Used as a thyroid hormone replacement for hypothyroidism.", "34068-7": "Take 1 tablet daily on an empty stomach or as directed.", "34071-1": "Do not exceed recommended dose. Keep out of reach of children.", "50565-1": "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately.", "51727-6": "Calcium stearate, dextrose, maltodextrin, mineral oil, modified wheat starch", "55105-1": "Thyroid hormone replacement", "55106-9": "Thyroid 90 mg", "NDC 17224-504-60": "Package label for NP Thyroid 90 mg tablets (60 tablets per bottle). Contains product name, dosage strength, , manufacturer/repacker name, and usage instructions as printed on the label."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:43.323679 · Updated: 2026-03-14T23:09:39.646164