Label: ACETAMINOPHEN tablet
- NDC Code(s): 36800-665-10, 36800-665-21, 36800-665-40
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 18, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each gelcap)
- 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
- 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 reach of children
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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 use for more than 10 days unless directed by a doctorchildren under 12 years
ask a doctor
- Other information
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Inactive ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, p ovidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-665 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 D&C RED NO. 33 (UNII: 9DBA0SBB0L) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) FD&C RED NO. 40 (UNII: WZB9127XOA) SHELLAC (UNII: 46N107B71O) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STARCH, CORN (UNII: O8232NY3SJ) AMMONIA (UNII: 5138Q19F1X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE K30 (UNII: U725QWY32X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Product Characteristics Color gray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code G1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-665-21 225 in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2024 2 NDC:36800-665-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2024 3 NDC:36800-665-40 400 in 1 BOTTLE; Type 0: Not a Combination Product 10/14/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/14/2024 Labeler - TOPCO ASSOCIATES LLC (006935977)