Label: PREMIER VALUE- cough drops cherry lozenge

  • NDC Code(s): 68016-883-30
  • Packager: Pharmacy Value Alliance LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 31, 2023

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  • Active Ingredient(s)

    Menthol 5.8 mg

  • Purpose

    Purposes cough suppressant, oral anesthetic

  • Use

    temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

  • Warnings

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

  • ASK 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).

  • STOP USE

    Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    ■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.

    ■ children under 5 years: ask a doctor.

  • Other information

    ■ 10 calories per drop ■ contains: SOY.

  • Inactive ingredients

    Glucose syrup, eucalyptus oil, FD&C blue 2, FD&C red 40, flavors, sucrose, sucralose, soy lechitin, water

  • QUESTIONS

    Or, to report an adverse event, call 800-245-2898.
    Monday - Friday, 9 AM to APM EST

  • Package Label - Principal Display Panel

    PV label

    30 Drops NDC: 68016-883-30

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE 
    cough drops cherry lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-883
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeOVALSize21mm
    FlavorMENTHOLImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-883-3030 in 1 BAG; Type 0: Not a Combination Product07/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/2023
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - Medical Group Care LLC (085137089)
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