Acetaminophen and Ibuprofen

Acetaminophen and Ibuprofen by

Drug Labeling and Warnings

Acetaminophen and Ibuprofen by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN AND IBUPROFEN- acetaminophen and ibuprofen tablet 
Granules India Limited

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Acetaminophen and Ibuprofen

PRINCIPAL DISPLAY PANEL

ACETAMINOPHEN AND IBUPROFEN 
acetaminophen and ibuprofen tablet

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-588
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	125 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
POVIDONE K90 (UNII: RDH86HJV5Z)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow (Light yellow to yellow colored)	Score	no score
Shape	CAPSULE (capsule shaped, biconvex)	Size	14mm
Flavor		Imprint Code	G;131
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-588-32	10000 in 1 DRUM	08/30/2023
2	NDC: 62207-588-85	90000 in 1 DRUM	03/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/30/2023

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	analysis(62207-588) , manufacture(62207-588)

Revised: 7/2024

Document Id: 1ce235f8-0661-58b3-e063-6294a90a947b

53409-9

Set id: 04220712-9ced-17ff-e063-6294a90ac4d5

Version: 2

Effective Time: 20240710