ACETAMINOPHEN 500 MG ROUND- acetaminophen tablet

Acetaminophen 500 mg by

Drug Labeling and Warnings

Acetaminophen 500 mg by is a Otc medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 500 MG  ROUND
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-538
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POVIDONE K30 (UNII: U725QWY32X)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	L;1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-538-87	15000 in 1 BOX; Type 0: Not a Combination Product	02/13/2023
2	NDC: 62207-538-85	90000 in 1 BOX; Type 0: Not a Combination Product	02/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		02/13/2023

Labeler - Granules India Limited (915000087)

Registrant - Granules India Limited (918609236)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-538) , analysis(62207-538) , pack(62207-538) , label(62207-538)