Ibuprofen 400 Mg - 600 Mg And 800 Mg Tablets

SPL v6

SPL

SPL Set ID 9b02607a-6fab-5205-e053-2a95a90afa26

Route

ORAL

Published

Effective Date 2018-08-27

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (800 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: 123 Shape: capsule Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2015-12-30

Description

800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with 123 on one side and plain on other side) NDC 68071-5140-3 BOTTLES OF 3 NDC 68071-5140-6 BOTTLES OF 6

Medication Information

Dosage Forms and Strengths

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

NDC 68071-5140-3 BOTTLES OF 3

NDC 68071-5140-6 BOTTLES OF 6

Description

800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with 123 on one side and plain on other side) NDC 68071-5140-3 BOTTLES OF 3 NDC 68071-5140-6 BOTTLES OF 6

Section 42231-1

Section 51945-4

Structured Label Content

Dosage Forms and Strengths (34069-5)

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

NDC 68071-5140-3 BOTTLES OF 3

NDC 68071-5140-6 BOTTLES OF 6

Section 42231-1 (42231-1)

Section 51945-4 (51945-4)

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IBUPROFEN", "unii": "WK2XYI10QM", "classCode": "ACTIB", "strengthNumerator": "800", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34069-5": "800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with 123 on one side and plain on other side) NDC 68071-5140-3 BOTTLES OF 3 NDC 68071-5140-6 BOTTLES OF 6"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:44:42.500711 · Updated: 2026-03-14T22:20:59.493265