Label: ACETAMINOPHEN tablet
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NDC Code(s):
0363-9798-05,
0363-9798-10,
0363-9798-15,
0363-9798-21, view more0363-9798-24, 0363-9798-37
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 17, 2024
If you are a consumer or patient please visit this version.
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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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of the reach of children.
- Overdose warning
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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 take 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, 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.
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9798 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 HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) AMMONIA (UNII: 5138Q19F1X) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ISOPROPYL ALCOHOL (UNII: ND2M416302) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color gray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Score score with uneven pieces Shape OVAL Size 19mm Flavor Imprint Code G1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9798-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2021 2 NDC:0363-9798-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2021 3 NDC:0363-9798-15 150 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2022 4 NDC:0363-9798-21 225 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2022 5 NDC:0363-9798-37 375 in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2022 6 NDC:0363-9798-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/24/2021 Labeler - WALGREEN CO. (008965063)