Label: CEPACOL SORE THROAT- dyclonine hydrochloride and glycerin liquid

  • 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 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dyclonine Hydrochloride 0.1%Oral pain reliever
    Glycerin 33%Oral demulcent
  • 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
  • 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 producttry to avoid swallowing spray.

  • 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
  • Other information

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

  • Questions?

    1-888-963-3382

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    CEPACOL  SORE THROAT
    dyclonine hydrochloride and glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-781
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE0.1 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN33 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-781-74118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/201109/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/20/201109/01/2024
    Labeler - RB Health (US) LLC (081049410)
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