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

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains associated with

    ■ headache

    ■ muscular aches

    ■ minor arthritis pain

    ■ toothache

    ■ menstrual cramps

    ■ common cold

    temporarily reduces fever

  • 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

    Ask a doctor before use if you have

    ■ liver disease

    Ask a doctor or pharmacist before use if

    ■ you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    ■ symptoms do not improve

    ■ redness or swelling is present

    ■ pain or fever persists or gets worse

    ■ new symptoms occur

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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

    Other information

    ■ store at room temperature 59º-86ºF (15º-30ºC)

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide.

  • QUESTIONS

    Questions? 1-800-835-2263

  • PhysiciansCare XS Non Aspirin Label

    Physicians Care®

    Extra Strength Non Aspirin

    Pain Reliever and Fever Reducer

    Pull To Open

    Coated Tablets

    Individually packaged for workplace use

    Tamper-Evident Packets of 2 Tablets

    Do not use if packet is open or torn.

    Aceatminiphen 500 mg

    100 Tablets (50 Packets, 2 tablets each)

    90016

    Physicians Care

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE NON ASPIRIN  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0123-0150 in 1 CARTON01/20/2012
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-0123-02125 in 1 CARTON01/20/2012
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-0123-0310 in 1 CARTON01/20/2012
    32 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-0123-002 in 1 PACKET; Type 0: Not a Combination Product01/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/20/2012
    Labeler - Acme United Corporation (001180207)
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