Label: PHYSICIANSCARE NON ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 0924-0128-01, 0924-0128-02, 0924-0128-03
  • Packager: Acme United Corporation
  • Category: HUMAN OTC DRUG LABEL

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 February 27, 2017

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  • Drug Facts

    Active ingredient (in each tablet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    For the temporary relief of minor aches and pains associated with

    ■ headache

    ■ muscular aches

    ■ minor arthritis pain

    ■ common cold

    ■ toothache

    ■ menstrual cramps

    For the reduction of fever.

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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

    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 using and ask a doctor if

    ■ symptoms do not improve

    ■ new symptoms occur

    ■ pain or fever persists or gets worse

    ■ redness or swelling is present

    Keep out of the 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.



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

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  • Directions

    do not use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets every 4 to 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 therecommended dose (overdose) and may cause liver damage.

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  • Other information

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

    ■ tamper-evident sealed packets

    ■ do not use any opened or torn packets

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  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

    * may contain

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  • Questions or comments?

    1-800-835-2263

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  • PhysiciansCare XS Non Aspirin Label

    Physicians Care®

    Extra Strength

    Non Aspirin

    Acetaminophen Fever Reducer & Pain Reliever

    Pull To Open

    Coated Tablets

    Tamper-Evident Packets of 2 Tablets

    250 Tablets (125 Packets 2 each)

    40800 PC XS Non Aspirin

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  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE NON ASPIRIN  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0128
    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 K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 12mm
    Flavor Imprint Code FR;33
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0924-0128-01 50 in 1 CARTON 01/20/2012
    1 2 in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:0924-0128-02 125 in 1 CARTON 01/20/2012
    2 2 in 1 PACKET; Type 0: Not a Combination Product
    3 NDC:0924-0128-03 10 in 1 CARTON 01/20/2012
    3 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 01/20/2012
    Labeler - Acme United Corporation (001180207)
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