Label: PAIN RELIEF- acetaminophen tablet, film coated
- NDC Code(s): 56062-227-71, 56062-227-78
- Packager: Publix Super Markets Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 November 25, 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. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if you have ever had an allergic reaction to this product or any of its ingredients
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Directions
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- do not take more than directed (see overdose warning)
adults and children 12 years and over
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- take 2 tablets every 6 hours while symptoms last
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- do not take more than 6 tablets in 24 hours, unless directed by a doctor
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- do not use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PAIN RELIEF
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-227 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 STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND (convex) Size 10mm Flavor Imprint Code L227 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-227-71 1 in 1 CARTON 11/26/2007 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:56062-227-78 1 in 1 CARTON 11/26/2007 2 100 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 not final part343 11/26/2007 Labeler - Publix Super Markets Inc (006922009)