Label: AC FAST- paracetamol capsule, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 81660-222-01 - Packager: GRIMANN SA DE CV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 2, 2021
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- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- PEDIATRIC USE
- PREGNANCY
- CONTRAINDICATIONS
- ADVERSE REACTIONS
- PURPOSE
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AC FAST
paracetamol capsule, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81660-222 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 1 U Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81660-222-01 10 U in 1 BLISTER PACK; Type 0: Not a Combination Product 04/01/2021 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2021 Labeler - GRIMANN SA DE CV (812806982) Registrant - GRIMANN SA DE CV (812806982) Establishment Name Address ID/FEI Business Operations GRIMANN SA DE CV 812806982 manufacture(81660-222)
