Label: BERRY BREEZER THROAT DROPS- pectin lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 9, 2016

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  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Pectin 7.0 mg

  • PURPOSE

    Purpose

    Oral demulcent

  • INDICATIONS & USAGE

    Uses temporarily relieves:

    occasional minor mouth irritation and sore throat

  • WARNINGS

    Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms 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 consult doctor if

    cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    sore throat is severe, or irritation, pain or redness lasts or worsens

    sore mouth does not improve in 7 days

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 5 years and over - allow 1 drop to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

    children under 5 years - ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: Artificial flavors, coconut oil, corn starch, FD&C red #40, glucose syrup, glycerin, malic acid, medium chain triglycerides, soybean oil, soy lecithin, sucrose, titanium dioxide, and water.

  • QUESTIONS

    Questions? Or to report an adverse event call 1-800-245-2898, Monday - Friday, 9AM to 4PM EST

  • PRINCIPAL DISPLAY PANEL

    CVS Berry Breezer Throat Drop 25ct

  • INGREDIENTS AND APPEARANCE
    BERRY BREEZER THROAT DROPS 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-595
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (red with white stripe) Scoreno score
    ShapeOVALSize20mm
    FlavorBERRYImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-595-2525 in 1 BAG; Type 0: Not a Combination Product05/18/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/18/2015
    Labeler - CVS Pharmacy (062312574)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(59779-595)
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