AC FAST- paracetamol capsule, coated
GRIMANN SA DE CV

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AC FAST
paracetamol capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81660-222
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg in 1 U

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)	54 mg in 1 U
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)	19 mg in 1 U
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)	15 mg in 1 U
MAGNESIUM STEARATE (UNII: 70097M6I30)	2 mg in 1 U
POLYVINYL ALCOHOL/POLYVINYL ACETATE COPOLYMER (4:1; 9500 MW) (UNII: 2AVG41YG39)	12 mg in 1 U

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	OVAL	Size	12mm
Flavor		Imprint Code	500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81660-222-01	10 U in 1 BLISTER PACK; Type 0: Not a Combination Product	04/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	04/01/2021

Labeler - GRIMANN SA DE CV (812806982)

Registrant - GRIMANN SA DE CV (812806982)

Name	Address	ID/FEI	Business Operations
Establishment
GRIMANN SA DE CV		812806982	manufacture(81660-222)