Label: ACETAMINOPHEN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-2783-0, 50090-2783-1 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 63739-440
- 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 March 1, 2021
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
- Purpose
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Warnings
Alcohol warning:
If you consume 3 or more alcoholic drinks every day, ask
your doctor whether you should take acetaminophen or other pain relievers/fever
reducers. Acetaminophen may cause liver damage. -
DOSAGE & ADMINISTRATION
Directions
Adults and children 12 years of age and older
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- take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.
Children 6-11 years of age
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- Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.
Children under 6 years of age
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- Do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- HOW SUPPLIED
- Acetaminophen
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-2783(NDC:63739-440) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code AZ;010 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2783-0 30 in 1 BOX, UNIT-DOSE 01/12/2017 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50090-2783-1 25 in 1 BOX, UNIT-DOSE 07/11/2017 2 30 in 1 BLISTER PACK; 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 03/01/2009 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-2783) , REPACK(50090-2783)
