Label: CLEMASTINE FUMARATE tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 21, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)

  • Purpose

    Antihistamine

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • Warnings

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions

    adults and children 12 years and older:

    1 tablet every 12 hours; not more than 2 tablets in 24 hours

    children under 12 years:

    ask a doctor
  • Other Information

    • Safety sealed: do not use if the imprinted bottle seal is open or torn.
    • Store at 20°-25°C (68°-77°F).
  • Inactive Ingredients

    Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn).

    Questions or comments?

    1-800-525-8747

  • PRINCIPAL DISPLAY PANEL

    Clemastine Fumarate 1.34 mg Label

    NDC 54868-5913-0

    Clemastine

    Fumarate

    Tablets, USP

    1.34 mg

    100 Tablets


    Antihistamine

    12 Hour Relief

    Relief of: Sneezing Runny Nose

    Itchy, Watery Eyes



  • INGREDIENTS AND APPEARANCE
    CLEMASTINE FUMARATE 
    clemastine fumarate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5913(NDC:0781-1358)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLEMASTINE FUMARATE (UNII: 19259EGQ3D) (CLEMASTINE - UNII:95QN29S1ID) CLEMASTINE FUMARATE1.34 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeCAPSULE (capsule shaped) Size4mm
    FlavorImprint Code GG;159
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5913-0100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07345806/27/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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

More Info on this Drug

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