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 Good Sense (geiss, Destin & Dunn, 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
Phenol 1.4%
Purpose
Oral Anesthetic/Analgesic
Uses
temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.
When Using This Product,
do not exceed recommended dose.
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 health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.
Directions
- adults and children 6 years of age and older
- apply to affected area ( one spray)
- allow to remain in place for at least 15 seconds, then spit out
- use every 2 hours as directed by a doctor or dentist
- children under 12 years of age should be supervised in the use of this product
- children under 6 years of age, consult a doctor or dentist
Other Information
- store at 20-25°C (68°-77°F). Do not refrigerate.
Inactive Ingredients
alcohol, FD&C red #40, flavour glycerin, purified water, saccharin sodium anhydrous
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Fast Relief
Sore Throat Spray
Phenol 1.4%
Oral Anesthetic/Analgesic
Relieves sore throat
- alcohol 0.10%
- aspirin-free
- sugar-free
Cherry Flavor
FL OZ (mL)
*Compare to the active Ingredient of Chloraseptic®*
*This product is not manufactured or distributed by Prestige Brands, distributor of Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR TORN.
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
Product Label
Good Sense Sore Throat Spray Cherry
* Please review the disclaimer below.