FDA Label for Sore Throat Menthol
View Indications, Usage & Precautions
Sore Throat Menthol Product Label
The following document was submitted to the FDA by the labeler of this product Amerisourcebergen (good Neighbor Pharmacy) 46122. 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 that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.
When Using This Product,
do not use more than directed.
Stop Use And Ask A Doctor If
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
- difficulty in breathing occurs
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 Poison Control Center (1-800-222-1222) right away.
Directions
- apply to the affected area
- use every 2 hours
- allow to remain in place for at least 15 seconds, then spit out
age | dose |
adults and children 12 years and over | for each application, spray 5 times |
children 3 to 11 years | should be supervised in use of this product for each application, spray 3 times |
children under 3 years | ask a doctor or dentist |
Other Information
- store at 20°-25°C (68°-77°F). Do not refrigerate.
Inactive Ingredients
D&C green #5, D&C yellow #10, FD&C green #3, glycerin, menthol, purified water, saccharin sodium
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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Compare to Chloraseptic® active ingredient*
Instant Acting
Sore Throat Spray
Phenol/Oral Anesthetic
Relieves Sore Throat
Menthol
- Alcohol Free
- Aspirin Free
- Sugar Free
FL OZ (mL)
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.
Distributed by AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087
Visit us at www.goodneighborpharmacy.com
Package Label
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