Label: PAIN RELIEVER- acetaminophen tablet, film coated
- NDC Code(s): 68016-543-01, 68016-543-24, 68016-543-99
- Packager: Chain Drug Consortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 10, 2024
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 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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
Premier
Value®*COMPARE TO THE ACTIVE INGREDIENT
IN EXTRA STRENGTH TYLENOL® CAPLETSEXTRA STRENGTH
Pain Reliever
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER100 Caplets - 500 mg each
actual
sizeTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Extra Strength Tylenol®
Caplets.50844 ORG062117512
Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.Premier Value 44-175
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-543 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 CASTOR OIL (UNII: D5340Y2I9G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;175 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-543-24 1 in 1 CARTON 04/29/2022 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:68016-543-01 1 in 1 CARTON 04/29/2022 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:68016-543-99 1 in 1 CARTON 04/29/2022 3 225 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 Drug M013 04/29/2022 Labeler - Chain Drug Consortium (101668460) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(68016-543) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(68016-543) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(68016-543) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(68016-543) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(68016-543) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117597853 pack(68016-543)