Label: ACETAMINOPHEN tablet

  • 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 April 5, 2011

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

View All Sections
  • Drug Facts

    Active ingredient (in each caplet)

    Acetaminophen .....................500 mg

  • PURPOSE

    Pain Reliever/ Fever Reducer

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • the common cold
    • backache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • premenstrual and menstrual cramps

    temporarily reduces fever

  • Warnings

    Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

    Do not use with any other drug containing acetaminophen

    Stop use and ask a doctor if

    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    Indicated for pain relief.

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

    Keep out of reach of children.

  • Overdose Warning:

    Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions: do not take more than directed (see overdose warning)

    adults and children 12 years and over
    • take 2 caplets every 6 hours as needed.
    • do not take more than 8 caplets in 24 hours
    • do not use more than 10 days unless directed by a doctor

    children under 12 years
    • do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.
  • Other Information

    • store between 20°- 25°C (68°- 77°F)
    • do not use if the box is opened
  • Inactive Ingredients

    Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®

    Questions or Comments?
    Call 1-866-383-9908

    Manufactured by:

    Cispharma Inc
    1212 Cranbury S River Road
    Cranbury, NJ 08512

  • PRINCIPAL DISPLAY PANEL

    ACETAMINOPHEN CAPLETS, 500 MG, Bulk
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52204-115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code C;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52204-115-9926549 in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/28/2011
    Labeler - Cispharma, Inc (833171445)
    Registrant - Cispharma, Inc (833171445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cispharma, Inc833171445manufacture
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!