FDA Label for Sore Throat
View Indications, Usage & Precautions
Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc. 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.
Active Ingredient(S)
Phenol 1.4%
Purpose
Oral pain reliever
Use(S)
for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.
Warnings
Sore Throat Warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by doctor.
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
▪ sore mouth symptoms do not improve in 7 days▪ irritation, pain or redness persists or worsens▪ swelling, rash or fever develops
If Pregnant Or Breast Feeding
ask a doctor before use.
Keep Out Of Reach Of Children
If more than used for minor mouth or throat pain is accidentally swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
Directions
▪ Adults and children 12 years of age and older:
Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, and then spit out.▪ Use every 2 hours or as directed by a doctor or dentist.▪ Children 6 years to under 12 years of age: should be supervised in the use of this product.▪ Children under 6 years: Consult a doctor or dentist.
Other Information
• Store at room temperature• Check expiration date before using.
Inactive Ingredients
FD&C Red No. 40, flavor, glycerin, purified water, sucralose
Questions Or Comments?
1-866-467-2748
Principal Display Panel
*Compare to the active ingredient in Chloraseptic®
NDC# 68163-703-06
SORE THROAT SPRAY
Phenol/Oral Pain Reliever
Fast Acting
Numbs on Contact
SUGAR-FREE
ASPIRIN-FREE
NATURAL CHERRY FLAVOR
6 FL OZ (177 mL)
Tamper-Evident: Do not use if imprinted shrink band is broken or missing.
Distributed by:
*This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Chloraseptic®.
* Please review the disclaimer below.