ibuprofen 400 mg - 600 mg and 800 mg tablets

SPL v3

SPL

SPL Set ID 999aa615-72b2-9296-e053-2a95a90ac70b

Route

oral

Published

Effective Date 2018-08-27

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

ibuprofen (400 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: 121 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

anda active Since 2015-12-30

How Supplied

400mg (white to of white, round, biconvex, film coated tablets debossed with 121 on one side and plain on the other side) NDC 68071-5134-6

Description

400mg (white to of white, round, biconvex, film coated tablets debossed with 121 on one side and plain on the other side) NDC 68071-5134-6

Medication Information

How Supplied

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

NDC 68071-5134-6

Description

400mg (white to of white, round, biconvex, film coated tablets debossed with 121 on one side and plain on the other side) NDC 68071-5134-6

Section 51945-4

Ibuprofen Tablets 400 Mg 600 Mg 800 Mg Medguide

Structured Label Content

How Supplied (HOW SUPPLIED)

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

NDC 68071-5134-6

Section 51945-4 (51945-4)

Ibuprofen Tablets 400 Mg 600 Mg 800 Mg Medguide (ibuprofen tablets 400 mg - 600 mg- 800 mg medguide)

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": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"HOW SUPPLIED": "400mg (white to of white, round, biconvex, film coated tablets debossed with 121 on one side and plain on the other side) NDC 68071-5134-6"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:41:36.938057 · Updated: 2026-03-14T22:06:14.611829