VICKS VAPODROPS COUGH RELIEF (MENTHOL) LOZENGE [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]

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VICKS VAPODROPS COUGH RELIEF (MENTHOL) LOZENGE [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]
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NDC 58933-679-20
Set ID 6998350b-5381-7e61-e053-2a91aa0adb20
Category HUMAN OTC DRUG LABEL
Packager Procter & Gamble Manufactura S de RL de CV
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per drop)

    Menthol 1.7 mg

  • Purpose

    Cough suppressant/oral anesthetic

  • Uses

    temporarily relieves

    • cough due to a cold or inhaled irritants
    • minor sore throat
  • Warnings

    Sore Throat Warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by doctor.

    Ask a doctor before use if you have

    • cough accompanied by excessive phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • a severe sore throat accompanied by difficulty in breathing or that lasts more than 2 days

    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. These could be signs of a serious condition.
    • sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    adults & children 5 yrs. & olderdissolve 3 drops (one at a time) slowly in the mouth
    children 2 to under 5 yrs.ask a doctor
    children under 2 yrs.do not use

    Repeat every 2 hours as needed or as directed by a doctor.

  • Other information

    • store at room temperature
  • Inactive ingredients

    ascorbic acid, citric acid, eucalyptus oil, FD&C Blue No. 1, FD&C Red No. 40, flavor, liquid glucose, sucrose

  • Questions?

    1-800-707-1709

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati OH 45202

  • PRINCIPAL DISPLAY PANEL - 20 Drop Bag Carton

    VICKS ®

    VapoDrops ™

    COUGH RELIEF
    CHERRY FLAVOR

    Menthol Cough Suppressant/
    Oral Anesthetic

    20 Drops

    See Drug Facts

    Principal Display Panel - 20 Drop Bag Carton
  • INGREDIENTS AND APPEARANCE
    VICKS VAPODROPS  COUGH RELIEF
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-679
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.7 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScoreno score
    ShapeTRIANGLESize16mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58933-679-201 in 1 CARTON04/30/2009
    120 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/2009
    Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)
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