Label: REGULAR STRENGTH ACETAMINOPHEN- acetaminophen tablet
- NDC Code(s): 71679-076-00
- Packager: Health Pharma USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 3, 2025
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- Official Label (Printer Friendly)
- Active Ingredient
- 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
- If pregnant or breast-feeding
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Keep out of reach of children.
Overdose warning:Taking more than the reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage. -
Directions
- do not use more than directed (see overdose warning)
- Adults and children 12 years of age and older:
- 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 more than 10 days unless directed by a doctor.
- Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGULAR STRENGTH ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71679-076 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, PREGELATINIZED CORN (UNII: O8232NY3SJ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) HYPROMELLOSES (UNII: 3NXW29V3WO) CARNAUBA WAX (UNII: R12CBM0EIZ) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code APAP325 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71679-076-00 1 in 1 BOX 07/31/2017 1 44750 in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/31/2017 Labeler - Health Pharma USA LLC (080804485) Establishment Name Address ID/FEI Business Operations Health Pharma USA LLC 080804485 manufacture(71679-076)