Label: LEADER COUGH TABS- guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 13, 2012

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  • ACTIVE INGREDIENT


    Active ingredient (per tablet)

    Guaifenesin  200mg
  • Purpose

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 
    • helps make coughs more productive
  • Warnings

    Ask doctor before use if you have

    • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
    • cough is accompanied by excessive phlegm (mucus)
  • STOP USE

    Stop use and ask doctor if

    • Symptoms are accompanied by fever, rash or persistent headache
    • cough persists for more than 1 week or tends to recur
    A persistent cough may be a sign 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 immediately.

  • Directions

    • Adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours as needed
    • Children 6 to 10 under 12 years of age: take 1/2 to 1 tablet every 4 hours as needed
    • Children under 6 years of age: consult a doctor    
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor
  • Other Information

    store at 15°-30°C (59°-86°F)

  • Inactive ingredients

    FD C red No. 40 (Al-lake), magnesium stearate,  maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    LEADER COUGH TABS 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-466
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorred (rose) Score2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code 151
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-466-721 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2005
    Labeler - Cardinal Health (097537435)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel(37205-466) , repack(37205-466)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc187824339manufacture(37205-466)
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