Label: ACETAMINOPHEN 325MG- acetaminophen tablet
- NDC Code(s): 45861-085-01
- Packager: Pharmaceutica North America, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 10, 2025
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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 4,000 mg 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 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
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user istaking the blood thinning drug warfarin
Stop use and ask a doctor if
• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• 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, ask a health professional before use.
Keep out of the reach of children.
Overdose warning:
In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. - 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 a 2 tablets, every 4 to 6 hours while symptoms last
- do not take more than 10 tablets in 24 hours, unless direact by a doctor
- do not use more than 10 days unless directed by a doctor
children 6 to under 12 years - take a one tablet, every 4 to 6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
- do not use more than 5 days unless directed by a doctor
children under 6 years ask a doctor - Other information
- Inactive Ingredients
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- Product label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325MG
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45861-085 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 POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (Off White) Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45861-085-01 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/01/2025 Labeler - Pharmaceutica North America, Inc. (962739699)
