Label: ACETAMINOPHEN tablet
- NDC Code(s): 69848-008-10
- Packager: Granules USA, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Liver warning
- Allergy alert
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of the reach of children.
- overdose warning
-
Directions
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
- Other information
-
Inactive ingredients
ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.
- Questions or comments?
- Acetaminophen, USP 500 mg Rapid Release Gelcaps
- PDP
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69848-008 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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) D&C RED NO. 33 (UNII: 9DBA0SBB0L) AMMONIA (UNII: 5138Q19F1X) GELATIN (UNII: 2G86QN327L) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color gray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Score no score Shape OVAL Size 19mm Flavor Imprint Code G1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69848-008-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 05/01/2020 Labeler - Granules USA, Inc (137098864)