Label: MCKESSON ACETAMINOPHEN 325- acetaminophen tablet, coated
- NDC Code(s): 68599-4679-9
- Packager: McKesson Medical-Surgical, Inc.
- 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 June 3, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg in 24 hours, which is the maximum daily amount
■ 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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
■ do not use more than directed (see overdose warning)
Adults and children: (12 years and over)
■ take 2 tablets every 4 to 6 hours while symptoms last.
■ do not take more than 10 tablets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
Children under 12 years:
■ Ask a doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MCKESSON ACETAMINOPHEN 325
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-4679 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code AZ;234 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68599-4679-9 250 in 1 BOX 04/01/2021 1 2 in 1 PACKET; 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 04/01/2021 Labeler - McKesson Medical-Surgical, Inc. (023904428) Registrant - Unifirst Fiirst Aid Corporation (832947092)