ROBITUSSIN MUCUS PLUS CHEST CONGESTION (GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]

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ROBITUSSIN MUCUS PLUS CHEST CONGESTION (GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]
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NDC 0031-8724-12
Set ID 259c8b69-c625-4146-b888-34ef43b8385f
Category HUMAN OTC DRUG LABEL
Packager Richmond Division of Wyeth
Generic Name
Product Class
Product Number
Application Number PART341
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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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