Label: PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated
- NDC Code(s): 0924-0123-00, 0924-0123-01, 0924-0123-02, 0924-0123-03
- Packager: Acme United Corporation
- 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 January 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 8 tablets 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
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
drug contains acetaminophen, ask a doctor or pharmacist.■ for more than 10 days for pain unless directed by a doctor
■ for more than 3 days for fever unless directed by a doctor
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DOSAGE & ADMINISTRATION
Directions
■ do not use more than directed
Adults and children: (12 years and older)
- take 2 tablets every 6 hours as needed.
- do not take more than 8 tablets in 24 hours.
Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- QUESTIONS
- PhysiciansCare XS Non Aspirin Label
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INGREDIENTS AND APPEARANCE
PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0123 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 HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code AZ;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0123-01 50 in 1 CARTON 01/20/2012 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-0123-02 125 in 1 CARTON 01/20/2012 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-0123-03 10 in 1 CARTON 01/20/2012 3 2 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:0924-0123-00 2 in 1 PACKET; Type 0: Not a Combination Product 01/20/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/20/2012 Labeler - Acme United Corporation (001180207)