Label: FORTOLIN- 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 June 23, 2014

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

  • ACTIVE INGREDIENT

    Active ingredients
    Acetaminophen 500 mg

  • PURPOSE

    Purpose
    Pain reliever-fever reducer

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of minor aches and pains associated with the common cold
    headache
    toothache
    muscular aches
    To reduce fever

  • WARNINGS

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

  • DO NOT USE

    Do not use
    on children under 3 years of age

  • STOP USE

    Stop use and ask a doctor if
    you need to use this product for pain for mroe than 10 days
    fever lasts for more than 3 days (72 hours) or ets worse
    new symptoms occur
    redness or swelling is present (these could be signs of a serious condition)

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    Take 1 tablet every 3 to 4 hours or 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.
    Children under 12 years of age : consult a docto

  • STORAGE AND HANDLING

    Other information
    Each tablet contains sodium 0.496 mg
    Keep tightly closed
    Store in original packaging, away from sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients
    colloidal silicon dioxide, corn starch, lactose, magnesium stearate, povidone, sodium starch glycolate

  • QUESTIONS

    Questions or comments?
    (888) 221-3496 M-F 9 am to 5 pm PST

  • PRINCIPAL DISPLAY PANEL

    Fortolin

    Pain Reliever Fever Reducer

    NDC 51467-127-24

    Aspirin Free

    Contain no aspirin and are unlikely to cause gastric irritation.

    Acetaminophen 500 mg

    24 Tablets

    Safety Sealed

    Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.

    Box1

  • INGREDIENTS AND APPEARANCE
    FORTOLIN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code F;O;R;T;O;L;I;N
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51467-127-2424 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/01/2004
    Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORTUNE PHARMACAL COMPANY, LIMITED686280561manufacture(51467-127)