Label: APHEN- acetaminophen tablet
- NDC Code(s): 76420-372-15
- Packager: Asclemed USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2023
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- Active Ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- adult takes more than 4,000mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
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Directions
Adults and children 12 years of age and older: take 2 tablets every 4 to 6 hours while symptoms last. Do not take more than 10 tablets in 24 hours, unless directed by a doctor. Do not use for more than 10 days unless directed by a doctor.
Children 6 years to under 12 years: take 1 tablet every 4 to 6 hours while symptoms last. Do not take more than 5 tablets in 24 hours. Do not use for more than 5 days unless directed by a doctor.
Children under 6 years of age: ask a doctor.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
APHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76420-372 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (white) Score no score Shape ROUND (Round) Size 10mm Flavor Imprint Code AZ;010 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76420-372-15 150 in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/04/2020 Labeler - Asclemed USA, Inc. (059888437)