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SPL v6

SPL

SPL Set ID 553c8cfa-cf0f-0b1f-e054-00144ff88e88

Route

ORAL

Published

Effective Date 2017-07-26

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

NDC 68071-3362-0 Bottles of 12 NDC 68071-3362-5 Bottles of 15 NDC 68071-3362-2 Bottles of 20 NDC 68071-3362-1 Bottles of 21 NDC 68071-3362-3 Bottles of 30 NDC 68071-3362-4 Bottles of 40 NDC 68071-3362-6 Bottles of 60 NDC 68071-3362-9 Bottles of 90

How Supplied

Medication Information

How Supplied

NDC 68071-3362-0 Bottles of 12

NDC 68071-3362-5 Bottles of 15

NDC 68071-3362-2 Bottles of 20

NDC 68071-3362-1 Bottles of 21

NDC 68071-3362-3 Bottles of 30

NDC 68071-3362-4 Bottles of 40

NDC 68071-3362-6 Bottles of 60

NDC 68071-3362-9 Bottles of 90

Description

800mg Ibuprofen Package Label

Structured Label Content

How Supplied (HOW SUPPLIED)

NDC 68071-3362-0 Bottles of 12

NDC 68071-3362-5 Bottles of 15

NDC 68071-3362-2 Bottles of 20

NDC 68071-3362-1 Bottles of 21

NDC 68071-3362-3 Bottles of 30

NDC 68071-3362-4 Bottles of 40

NDC 68071-3362-6 Bottles of 60

NDC 68071-3362-9 Bottles of 90

800mg Ibuprofen Package Label

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)

{"HOW SUPPLIED": "NDC 68071-3362-0 Bottles of 12 NDC 68071-3362-5 Bottles of 15 NDC 68071-3362-2 Bottles of 20 NDC 68071-3362-1 Bottles of 21 NDC 68071-3362-3 Bottles of 30 NDC 68071-3362-4 Bottles of 40 NDC 68071-3362-6 Bottles of 60 NDC 68071-3362-9 Bottles of 90"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:41:48.161124 · Updated: 2026-03-14T22:06:52.986948