FDA Label for Cepacol Sore Throat
View Indications, Usage & Precautions
Cepacol Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Do not exceed recommended dosage.
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| 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
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - When Using
When using this product try 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.
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
* Please review the disclaimer below.