Label: ACETAMINOPHEN 325MG RS- acetaminophen 325mg tablet
- NDC Code(s): 69168-010-30, 69168-010-50, 69168-010-60
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 7, 2019
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- Official Label (Printer Friendly)
- 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
Ask a doctor or pharmacist before use if
- the user is taking the blood thinning drug warfarin
- is a child with pain of arthritis
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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 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 6-11 years of age:
- 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: ask a doctor
- Other information
- Inactive ingredients
- Questions or Comments
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325MG RS
acetaminophen 325mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-010 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 Circle) Size 11mm Flavor Imprint Code AZ;010 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-010-60 1 in 1 CARTON 04/15/2016 1 60 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-010-50 1 in 1 CARTON 04/15/2016 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69168-010-30 1 in 1 CARTON 12/15/2021 3 30 in 1 BOTTLE; 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 04/15/2016 Labeler - Allegiant Health (079501930)
