Label: CEPACOL SORE THROAT- dyclonine hydrochloride and glycerin liquid
- NDC Code(s): 63824-781-74
- Packager: Reckitt Benckiser LLC
- 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.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients Purpose Dyclonine Hydrochloride 0.1% Oral pain reliever Glycerin 33% Oral demulcent
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
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
- 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, sorbitolClose
You may also report side effects to this phone number.Close
- SPL UNCLASSIFIED SECTION
Dist. by: Reckitt BenckiserClose
Parsippany, NJ 07054-0224
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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)
- 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 DEA Schedule 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 (UNII: L7T10EIP3A) phosphoric acid (UNII: E4GA8884NN) poloxamer 338 (UNII: F75JV2T505) potassium sorbate (UNII: 1VPU26JZZ4) sodium phosphate, dibasic (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 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)