Label: ACETAMINOPHEN tablet
- NDC Code(s): 60760-534-40
- Packager: St. Mary's Medical Park Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 0904-6720
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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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
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Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over
- 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 for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60760-534(NDC:0904-6720) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white Score no score Shape OVAL Size 16mm Flavor Imprint Code L484 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60760-534-40 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/07/2021 Labeler - St. Mary's Medical Park Pharmacy (063050751) Establishment Name Address ID/FEI Business Operations St Mary's Medical Park Pharmacy 063050751 relabel(60760-534) , repack(60760-534)