Label: CEPACOL SORE THROAT- dyclonine hydrochloride and glycerin liquid
- NDC Code(s): 63824-781-74
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
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Updated September 27, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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.
Keep out of the reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
INGREDIENTS AND APPEARANCE
CEPACOL SORE THROAT
dyclonine hydrochloride and glycerin liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-781 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE 0.1 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 33 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-781-74 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2011 09/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 05/20/2011 09/01/2024 Labeler - RB Health (US) LLC (081049410)