Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
direct rx
ORAL
OTC DRUG
OTC monograph not final
ACETAMINOPHEN TABLET direct rx 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. ---------- PlusPHARMA See New Warnings Information and Directions Extra Strength ACETAMINOPHEN 500 mg PAIN RELIEVER FEVER REDUCER CONTAINS NO ASPIRIN Compare to the Active Ingredient in Extra Strength Tylenol® This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Revised: 7/2023 Document Id: 00edb965-211c-d896-e063-6294a90a86ad 34390-5 Set id: aa6cc288-ad0d-92e2-e053-2995a90a9e16 Version: 2 Effective Time: 20230720 direct rx Olvassa el a teljes dokumentumot
PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- ACETAMINOPHEN TABLET DIRECT RX _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._ ---------- PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG PlusPHARMA See New Warnings Information and Directions Extra Strength ACETAMINOPHEN 500 mg PAIN RELIEVER FEVER REDUCER CONTAINS NO ASPIRIN Compare to the Active Ingredient in Extra Strength Tylenol® This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775. Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid. Do not use if imprinted safety seal under cap is broken or missing Store at room temperature PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG acetaminophen tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:72189-120(NDC:51645-706) 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 POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) PRODUCT CHARACTERISTICS COLOR white SCORE 2 pieces SHAPE ROUND SIZE 12mm FLAVOR IMPRINT CODE GPI;A5 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:72189-120- 50 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/14/2020 08/31/2023 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph not final part343 07/14/2020 08/31/2023 LABELER - direct rx (079254320) REGISTRANT - di Olvassa el a teljes dokumentumot