Ibuprofen 400 Mg - 600 Mg And 800 Mg Tablets

SPL v21

SPL

SPL Set ID 9dfc752f-3f66-4c39-bfa8-db6de9a9a9bf

Route

ORAL

Published

Effective Date 2024-12-11

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (800 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Completed Since 2016-11-17 Until 2018-06-28

Description

Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

How Supplied

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

Medication Information

Dosage Forms and Strengths

Ibuprofen tablets are available in the following strength:

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

NDC: 70518-0005-00

NDC: 70518-0005-01

NDC: 70518-0005-02

NDC: 70518-0005-03

NDC: 70518-0005-04

NDC: 70518-0005-05

NDC: 70518-0005-06

PACKAGING: 21 in 1 BLISTER PACK

PACKAGING: 14 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 10 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

“Preserve in well-closed containers”

Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature].

Rx only

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

How Supplied

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

Description

Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762

Principal Display Panel

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0005-0

NDC: 70518-0005-1

NDC: 70518-0005-2

NDC: 70518-0005-3

NDC: 70518-0005-4

NDC: 70518-0005-5

NDC: 70518-0005-6

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: 123

PACKAGING: 21 in 1 BLISTER PACK

PACKAGING: 14 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 10 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

IBUPROFEN 800mg in 1

INACTIVE INGREDIENT(S):

SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE

Ibuprofen Tablets 400 Mg 600 Mg 800 Mg Medguide

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

Structured Label Content

Dosage Forms and Strengths (34069-5)

Ibuprofen tablets are available in the following strength:

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

NDC: 70518-0005-00

NDC: 70518-0005-01

NDC: 70518-0005-02

NDC: 70518-0005-03

NDC: 70518-0005-04

NDC: 70518-0005-05

NDC: 70518-0005-06

PACKAGING: 21 in 1 BLISTER PACK

PACKAGING: 14 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 10 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

“Preserve in well-closed containers”

Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature].

Rx only

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

How Supplied (HOW SUPPLIED)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0005-0

NDC: 70518-0005-1

NDC: 70518-0005-2

NDC: 70518-0005-3

NDC: 70518-0005-4

NDC: 70518-0005-5

NDC: 70518-0005-6

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 19 mm

IMPRINT: 123

PACKAGING: 21 in 1 BLISTER PACK

PACKAGING: 14 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 10 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

IBUPROFEN 800mg in 1

INACTIVE INGREDIENT(S):

SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE

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

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

Advanced Ingredient Data

[{"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"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34069-5": "Ibuprofen tablets are available in the following strength: 800 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side) NDC: 70518-0005-00 NDC: 70518-0005-01 NDC: 70518-0005-02 NDC: 70518-0005-03 NDC: 70518-0005-04 NDC: 70518-0005-05 NDC: 70518-0005-06 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK “Preserve in well-closed containers” Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Rx only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762", "HOW SUPPLIED": "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", "PRINCIPAL DISPLAY PANEL": "DRUG: IBUPROFEN GENERIC: IBUPROFEN DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-0005-0 NDC: 70518-0005-1 NDC: 70518-0005-2 NDC: 70518-0005-3 NDC: 70518-0005-4 NDC: 70518-0005-5 NDC: 70518-0005-6 COLOR: white SHAPE: CAPSULE SCORE: No score SIZE: 19 mm IMPRINT: 123 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): IBUPROFEN 800mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE", "ibuprofen tablets 400 mg - 600 mg- 800 mg medguide": "Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:52:03.794007 · Updated: 2026-03-14T22:52:05.339754