Ibuprofen - DailyMed Details

Ibuprofen

SPL v11

SPL

SPL Set ID c3f30813-0848-6e8a-e053-2995a90a3dea

Route

ORAL

Published

Effective Date 2023-07-05

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (800 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: 122 Shape: capsule Color: white Size: 19 mm Size: 18 mm Score: 1

Marketing Status

ANDA Active Since 2021-06-04

Description

[MEDGUIDE IBUPROFEN TABLETS]

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

Description

[MEDGUIDE IBUPROFEN TABLETS]

Section 42231-1

[MEDGUIDE IBUPROFEN TABLETS]

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

Section 42231-1 (42231-1)

[MEDGUIDE IBUPROFEN TABLETS]

Section 51945-4 (51945-4)

Advanced Ingredient Data

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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", "42231-1": "[MEDGUIDE IBUPROFEN TABLETS]"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:45:04.454814 · Updated: 2026-03-14T22:21:48.727802