Label: CEPACOL SORE THROAT- dyclonine hydrochloride and glycerin liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Dyclonine Hydrochloride 0.1% Oral pain reliever
    Glycerin 33% Oral demulcent
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  • Uses

    for temporary relief of:

    • occasional minor irritation, pain, sore mouth, and sore throat
    • pain associated with canker sores
    • minor discomfort and protection of irritated areas in sore mouth and sore throat
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  • 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.

    Stop use and ask a doctor or dentist if

    • sore mouth symptoms do not improve in 7 days

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

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not exceed recommended dosage.

    When using this product try to avoid swallowing spray.

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  • Directions

    • adults and children 4 years of age and older: Spray 4 times into throat or affected area. Gargle, swish around or allow to remain in place at least 1 minute and then spit out. Repeat up to 4 times daily or as directed by a dentist or doctor. Children 4 to under 12 years of age should be supervised in the use of this product.
    • children under 4 years of age: do not use
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  • Other information

    • store at room temperature 20-25°C (68-77°F)
    • do not freeze
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  • Inactive ingredients

    cetylpyridinium chloride, D&C red #33, deionized water, FD&C yellow #6, flavor, menthol, phosphoric acid, poloxamer 338, potassium sorbate, sodium phosphate dibasic, sorbitol

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  • Questions?

    1-888-963-3382

    You may also report side effects to this phone number.

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  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 63824-781-74

    Cēpacol®

    SORE THROAT SPRAY

    Dyclonine HCl 0.1%Oral Pain Reliever
    Glycerin 33%
    Oral Demulcent

    Fast Sore Throat Relief

    • Instant Acting
    • Coats & Soothes

    4 FL OZ (118 mL)

    SUGAR FREE
    cherry

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    CEPACOL  SORE THROAT
    dyclonine hydrochloride and glycerin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-781
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dyclonine Hydrochloride (Dyclonine) Dyclonine Hydrochloride 0.1 g  in 100 mL
    Glycerin (Glycerin) Glycerin 33 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    cetylpyridinium chloride  
    D&C red No. 33  
    water  
    FD&C yellow No. 6  
    menthol  
    phosphoric acid  
    poloxamer 338  
    potassium sorbate  
    sodium phosphate, dibasic  
    sorbitol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-781-74 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 05/20/2011
    Labeler - Reckitt Benckiser LLC (094405024)
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