Label: CEPACOL SORE THROAT- dyclonine hydrochloride and glycerin liquid
Contains inactivated NDC Code(s)
NDC Code(s): 63824-781-74
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
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 December 12, 2018
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- Official Label (Printer Friendly)
- 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 05/20/2011 Labeler - RB Health (US) LLC (081049410)