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

If you are a consumer or patient please visit this version.

View All Sections
  • 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 not finalpart34301/20/2012
    Labeler - Acme United Corporation (001180207)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!