Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated
- NDC Code(s): 49035-531-12
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 26, 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 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
NDC 49035-531-12
equate™
Compare to
Extra Strength
Tylenol® Active
Ingredient**Extra Strength
Acetaminophen
500 mgPain Reliever/Fever Reducer
•Contains no aspirin
•Sweet coated
500
mg
EACH100
TABLETSActual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716
PRODUCT OF CHINA
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA
**This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Extra Strength Tylenol®.
50844 REV1220B53112 729665Satisfaction
guaranteed –
For questions or
comments
please call
1-888-287-1915.
Equate 44-531C
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-531 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:49035-531-12 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/11/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/11/2005 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(49035-531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(49035-531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(49035-531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(49035-531) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(49035-531)