Label: ACETAMINOPHEN REGULAR STRENGTH- acetaminophen tablet
- NDC Code(s): 41163-514-02
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 17, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. 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 the user is allergic to acetaminophen or any of the inactive ingredients in this product
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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
- do not use for more than 10 days unless directed by a doctor
children 6-11 years - 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 REGULAR STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-514 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, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code M2A3;57344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-514-02 1 in 1 CARTON 11/01/2014 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/01/2014 Labeler - United Natural Foods, Inc. dba UNFI (943556183)