Label: ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet
- NDC Code(s): 54257-720-02
- Packager: Magno-Humphries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 27, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- Uses
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Warnings
This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:
- more than 8 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drugs containing acetaminophen (prescription or nonprescription). 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
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days. These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over - take 2 tablets every 4 to 6 hours as needed
- do not take more than 8 tablets in 24 hours
- do not take for more than 10 days unless directed by a doctor
children 6-11 years - take 1 tablets every 4 to 6 hours as needed
- do not take more than 4 tablets in 24 hours
- do not take for more than 5 days unless directed by a doctor
children under 6 years do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. - Other information
- Inactive ingredients
- Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN REGULAR STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54257-720 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) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ010 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54257-720-02 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/24/2020 Labeler - Magno-Humphries, Inc. (063251433)
