Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet, film coated
- NDC Code(s): 0363-0531-12, 0363-0531-15, 0363-0531-29, 0363-0531-37
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 23, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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:
- blisters
- rash
- skin reddening
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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Walgreens
Compare to the active ingredient
in Extra Strength Tylenol®††
NDC 0363-0531-12
Pain
Reliever
ACETAMINOPHEN 500 mg /
PAIN RELIEVER / FEVER REDUCER
EXTRA STRENGTH
100
COATED
TABLETSACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†Our pharmacists recommend the Walgreens brand. We invite
you to compare to national brands.
††This product is not manufactured or distributed by Johnson
& Johnson Corporation, owner of the registered trademark
Extra Strength Tylenol®.
50844 ORG122053112DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2021 Walgreen Co.ITEM 243692
Walgreens B-2201-531C-12-HR ORG1220
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0531 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) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) 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) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color red Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;531 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0531-15 1 in 1 CARTON 12/11/2005 07/24/2024 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0363-0531-12 1 in 1 CARTON 12/11/2005 07/24/2024 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:0363-0531-37 1 in 1 CARTON 12/11/2005 04/23/2020 3 75 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0363-0531-29 150 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 12/11/2005 09/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/11/2005 07/24/2024 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0363-0531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(0363-0531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0363-0531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(0363-0531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0363-0531)