Label: COUGH- guaifenesin liquid

  • 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 February 9, 2011

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  • Active ingredient (in each 5 mL teaspoonful)

    Guaifenesin 100 mg

  • Uses

    helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

  • Warnings

    Ask a doctor before use if you have

    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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

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

  • Directions

    • take every four hours
    • do not take more than 6 doses in 24 hours
    adults and children 12 years and over2–4 teaspoonfuls
    children 6 to under 12 years1–2 teaspoonfuls
    children under 6 yearsdo not use
  • Other information

    • each teaspoonful contains: sodium 3 mg
    • store at room temperature 15°–30°C (59°–86°F)
  • Inactive ingredients

    caramel powder, citric acid, corn syrup, FD&C red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

  • QUESTIONS

    1-800-645-2158, 9 am – 5 pm ET, Monday – Friday

  • PURPOSE

  • TAMPER EVIDENT

    DO NOT USE IF INNER FOIL SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    Rebel Distributors Corp
    NDC 21695-705-04

    • FOR ADULTS AND CHILDREN
    • NON-NARCOTIC EXPECTORANT
    • ALCOHOL FREE

    Cough
    SYRUP
    Guaifenesin, USP

    4 fl oz (118 mL)

    Guaifenesin 100mg/5ml

  • INGREDIENTS AND APPEARANCE
    COUGH 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-705(NDC:0536-0825)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Caramel (UNII: T9D99G2B1R)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Menthol (UNII: L7T10EIP3A)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorPINK (Reddish-Pink) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-705-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/04/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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