Label: VICKS JARABE COUGH CONGESTION- dextromethorphan hbr and guaifenesin liquid

  • NDC Code(s): 37000-959-08
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 7.5 mL)


    Dextromethorphan HBr 5 mg
    Guaifenesin 100 mg

    Purpose

    Cough suppressant
    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • Warnings

    Do not use

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • a sodium-restricted diet
  • Stop use and ask a doctor if

    cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

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

  • Directions

    • only use the dose cup provided
    • do not exceed 6 doses per 24 hrs

    adults & children 12 yrs & over30 mL every 4 hrs
    children 6 to under 12 yrs15 mL every 4 hrs
    children 4 to under 6 yrs7.5 mL every 4 hrs
    children under 4 yrsdo not use
  • Other information

    • each 7.5 mL contains:sodium 23 mg

    • store at no greater than 25°C

  • Inactive ingredients

    citric acid, FD&C Red No. 40, flavors, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, water, xanthan gum

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if printed safety seal under cap is missing or damaged

  • SPL UNCLASSIFIED SECTION

    Made in Canada

    DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

    VICKS®

    Jarabe

    COUGH + CONGESTION

    Dextromethorphan HBr - Cough

    Guaifensin - Chest Congestion

    COATS & SOOTHES YOUR THROAT

    8 FL OZ (236 mL)

    959

  • INGREDIENTS AND APPEARANCE
    VICKS JARABE  COUGH CONGESTION
    dextromethorphan hbr and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-959
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 7.5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-959-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/23/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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