Ibuprofen - DailyMed Details

Ibuprofen

SPL v5

SPL

SPL Set ID d88d0544-57a7-4a82-e053-2a95a90a1945

Route

ORAL

Published

Effective Date 2023-07-05

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (400 mg)

Inactive Ingredients

Titanium Dioxide Croscarmellose Sodium Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Magnesium Stearate Silicon Dioxide Cellulose, Microcrystalline Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 121 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

ANDA Active Since 2022-02-21

Description

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500 600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500 800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)

Medication Information

Dosage Forms and Strengths

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)

Description

Section 51945-4

Structured Label Content

Dosage Forms and Strengths (34069-5)

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)

Section 51945-4 (51945-4)

Advanced Ingredient Data

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IBUPROFEN", "unii": "WK2XYI10QM", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34069-5": "400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500 600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500 800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:45:06.675429 · Updated: 2026-03-14T22:21:48.727802