FDA Label for Cepacol Ultra Sore Throat
View Indications, Usage & Precautions
Cepacol Ultra 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.
Flammable. Keep away from fire, flame or heat.
Distributed by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Benzocaine 5% | Oral pain reliever |
| Glycerin 33% | Oral demulcent |
Uses
for the 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
Allergy Alert
- Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.
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.
Otc - Stop Use
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 this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
When Using This Product
- do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor
- in rare cases, this product may cause a loss of sensation in the throat which is temporary and harmless
- to avoid swallowing difficulties, avoid eating, chewing gum or sucking on lozenges for 20 minutes after using
Directions
- adults and children 6 years of age and older: spray into throat or onto affected area with only ONE spray per use. Allow to remain in place for at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor
- children 6 to under 12 years of age should be supervised in the use of this product
- children under 6 years of age: do not use
Other Information
- tamper evident: product is sealed for your protection. Do not use if printed seal over nozzle is torn or missing.
- shake well before use
- store at room temperature 20-25°C (68-77°F)
- do not freeze
Inactive Ingredients
acesulfame potassium, deionized water, flavors, neotame, polyoxyl-40 hydrogenated castor oil, povidone K90, SD alcohol 38B
Questions?
Call 1-888-963-3382
You may also report side effects to this phone number.
Principal Display Panel - 22.2 Ml Bottle Carton
NDC 63824-780-75
Cēpacol®
ULTRA
SORE THROAT SPRAY
Benzocaine 5% | Oral Pain Reliever
Glycerin 33% | Oral Demulcent
Ultra1 SHOT for Pain Relief
Instant Acting • On-the-Go Comfort
100
Sprays
SUGAR FREE
cherry
0.75 FL OZ (22.2 mL)
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