Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated
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NDC Code(s):
41163-500-01,
41163-500-02,
41163-500-04,
41163-500-05, view more41163-500-06, 41163-500-17
- 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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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 are 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 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 EXTRA STRENGTH
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-500 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 HYPROMELLOSES (UNII: 3NXW29V3WO) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code M2A4;57344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-500-01 1 in 1 CARTON 11/01/2013 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:41163-500-02 1 in 1 CARTON 11/01/2013 05/31/2020 2 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:41163-500-04 1 in 1 CARTON 11/01/2013 3 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:41163-500-05 1 in 1 CARTON 11/01/2013 12/01/2019 4 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:41163-500-06 1 in 1 CARTON 11/01/2013 5 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 6 NDC:41163-500-17 1 in 1 CARTON 11/01/2013 03/31/2018 6 150 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 11/01/2013 Labeler - United Natural Foods, Inc. dba UNFI (943556183)