Ibuprofen 400 Mg - 600 Mg And 800 Mg Tablets

Ibuprofen 400 Mg - 600 Mg And 800 Mg Tablets
SPL v1
SPL
SPL Set ID 77adb094-869c-44b4-8a4e-b739ac9cd701
Route
ORAL
Published
Effective Date 2021-03-09
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (600 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: 122 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2015-12-30
Description

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

How Supplied

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

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)

How Supplied

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

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 600 mg
90 71610-532-60
180 71610-532-80
270 71610-532-92

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20210420JH

Principal Display Panel 600 Mg

NDC 71610-532 - Ibuprofen, USP 600 mg Tablets - Rx Only

Ibuprofen Tablets 400 Mg 600 Mg 800 Mg Medguide

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)

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) Bottles of 100 & 500

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 600 mg
90 71610-532-60
180 71610-532-80
270 71610-532-92

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20210420JH

Principal Display Panel 600 Mg (PRINCIPAL DISPLAY PANEL - 600 mg)

NDC 71610-532 - Ibuprofen, USP 600 mg Tablets - Rx Only

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:36:04.250318 · Updated: 2026-03-14T21:45:12.942518