VICKS FORMULA 44 COUGH AND HEAD CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

VICKS FORMULA 44 COUGH AND HEAD CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-449-12
Set ID 4ea0c6cd-5920-39fc-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 15 mL)

    Dextromethorphan HBr 15 mg

    Phenylephrine HCl 5 mg

  • Purpose

    Cough suppressant

    Nasal decongestant

  • Use

    temporarily relieves common cold symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
  • 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • a sodium-restricted diet

    When using this product, do not use more than directed.

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • nasal congestion or cough persist for more than one week or are accompanied by fever
    • cough 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 only as directed
    • use the dose cup provided
    • do not exceed 4 doses per 24 hours

    adults and children 12 years and over 30 mL every 4 hours

    children 6 to under 12 years 15 mL every 4 hours

    children 4 to under 6 years ask a doctor

    children under 4 years do not use

  • Other information

    • each tablespoon contains: sodium 45 mg
    • store at room temperature
  • Inactive ingredients

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

  • Questions?

    1-800-362-1683

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER&GAMBLE,

    CINCINNATI OH 45202.

  • PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

    VICKS®

    FORMULA

    44™

    ATTACKS COUGH AT THE SOURCE

    FAST

    RELIEF

    COUGH &

    HEAD CONGESTION

    Phenylephrine HCl :
    nasal decongestant

    Dextromethorphan HBr :

    cough suppressant

    Non-Drowsy

    BERRY FLAVOR

    NEW


    12 FL OZ (354 ml)

    449

  • INGREDIENTS AND APPEARANCE
    VICKS  FORMULA 44 COUGH AND HEAD CONGESTION
    dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-449
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-449-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/11/2017
    Labeler - The Procter & Gamble Manufacturing Company (004238200)

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