Label: ROBITUSSIN MUCUS PLUS CHEST CONGESTION- 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 March 27, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 10 mL)

    Guaifenesin, USP 200 mg

  • Purpose

    Expectorant

  • Use

    helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • Warnings

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such 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 is accompanied by fever, rash, or persistent headache. 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

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • ml=milliliter
    • this adult product is not intended for use in children under 12 years of age
    agedose
    adults and children 12 years and over10-20 ml every 4 hours
    children under 12 yearsdo not use
  • Other information

    • each 10 ml contains: sodium 4 mg
    • store at 20-25°C (68-77°F). Do not refrigerate
    • alcohol-free
  • Inactive ingredients

    anhydrous citric acid, artificial flavor, caramel, FD&C red no. 40, glycerin, high fructose corn syrup, liquid glucose, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

    Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Pfizer, Madison, NJ 07940 USA

    For most recent product information, visit www.robitussin.com

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    ADULT

    Robitussin®

    Mucus + Chest Congestion

    GUAIFENESIN (Expectorant)

    Alcohol-Free

    4 FL OZ (118 ml)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    ADULT

    Robitussin®

    Mucus + Chest
    Congestion

    GUAIFENESIN (Expectorant)

    Relieves:

    ✓
    Mucus
    ✓
    Chest Congestion

    Alcohol-Free

    ORIGINAL

    For Ages 12 & Over

    4 FL OZ
    (118 ml)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN MUCUS PLUS CHEST CONGESTION 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8724
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARAMEL (UNII: T9D99G2B1R)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorRED (deep wine) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8724-121 in 1 CARTON
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/18/2012
    Labeler - Richmond Division of Wyeth (829390835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fareva Richmond, Inc.969523245ANALYSIS(0031-8724) , LABEL(0031-8724) , MANUFACTURE(0031-8724) , PACK(0031-8724) , RELABEL(0031-8724) , REPACK(0031-8724)
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