ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [REMEDYREPACK INC.]

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ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [REMEDYREPACK INC.]
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NDC 61786-963-45
Set ID f73e1db1-cd54-4e1e-a739-4be0d73ac4a6
Category HUMAN OTC DRUG LABEL
Packager REMEDYREPACK INC.
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 2 TSP (10 mL) )

    Guaifenesin USP 200 mg

  • Purpose

    Expectorant

  • Uses

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

  • Warnings

    Ask a doctor before use if you have

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

    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 the 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
    • this product is not intended for use in children under 12 years of age
    • TSP = teaspoonful
    adults and children 12 years and over2 - 4 TSP every 4 hours
    children under 12 yearsdo not use
  • Other information

    • each TSP (5 mL) contains: sodium 3 mg
    • store at 20°-25°C (68°-77°F). Do not refrigerate.
  • Inactive ingredients

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

  • Questions or comments?

    (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    Distributed by
    MAJOR ® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233,
    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL

    DRUG: ROBAFEN COUGH FORMULA

    GENERIC: Guaifenesin

    DOSAGE: SYRUP

    ADMINSTRATION: ORAL

    NDC: 61786-963-45

    COLOR: brown

    FLAVOR: MENTHOL

    PACKAGING: 118 mL in 1 BOTTLE

    ACTIVE INGREDIENT(S):

    • Guaifenesin 100mg in 5mL

    INACTIVE INGREDIENT(S):

    • Corn Syrup
    • FD&C Red no. 40
    • Menthol, Unspecified Form
    • Caramel
    • Water
    • Glycerin
    • Sodium Benzoate
    • Propylene Glycol
    • Anhydrous Citric Acid
    • Saccharin Sodium

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    ROBAFEN COUGH FORMULA 
    guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-963(NDC:0904-0061)
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colorbrown (Reddish-Brown) Score    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61786-963-45118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/31/2016
    Labeler - REMEDYREPACK INC. (829572556)
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