Label: VICKS FORMULA 44 COUGH DROPS- menthol lozenge

  • NDC Code(s): 37000-997-50
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (per drop)

    Menthol 5.8 mg

  • Purpose

    Cough suppressant/Oral anesthetic

  • Uses

    temporarily relieves:

    • cough associated with a cold
    • occasional minor irritation or 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 12 years of age unless directed by doctor.

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • cough accompanied by excessive phlegm (mucus)
    • 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.
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens

    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

    • adults and children 12 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
    • children under 12 years of age: do not use
  • Other information

    • Store at 20°- 25°C (68°-77°F) in a dry place
    • Contains soy
  • Inactive ingredients

    corn syrup, eucalyptus oil, FD&C Red No. 40, flavors, sucrose, water

  • Questions?

    1-800-342-6844

  • SPL UNCLASSIFIED SECTION

    DIST. BY
    PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 50 Drop Bag

    VICKS®

    FORMULA 44™

    COUGH DROPS

    MENTHOL • Cough Suppressant / Oral Anesthetic

    Cooling Menthol

    Soothes Sore Throat

    Relieves Cough

    actual size

    50 MEDICATED DROPS

    997

  • INGREDIENTS AND APPEARANCE
    VICKS FORMULA 44  COUGH DROPS
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-997
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize23mm
    FlavorCHERRY (menthol) Imprint Code VICKS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-997-5050 in 1 BAG; Type 0: Not a Combination Product11/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02211/30/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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