Label: PAIN RELIEVER- acetaminophen tablet
- NDC Code(s): 0363-0792-29, 0363-0792-35, 0363-0792-40
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 6, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
-
Warnings
Liver warning:This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert:acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
- 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 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 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Carton Label)
-
INGREDIENTS AND APPEARANCE
PAIN RELIEVER
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0792 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (White to off White) Score no score Shape CAPSULE (Biconvex) Size 18mm Flavor Imprint Code N79 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0792-29 150 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2020 2 NDC:0363-0792-35 1 in 1 CARTON 06/12/2020 2 225 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-0792-40 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 06/12/2020 Labeler - WALGREEN CO. (008965063) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 manufacture(0363-0792)