Active Ingredient
Phenol 1.4%
Sore Throat Spray
FDA Label NDC 49035-376
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) for the product Sore Throat (NDC 49035-376). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product,, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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
alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium
Questions Or Comments?
Call 1-888-287-1915
Principal Display Panel
Compare to Chloraseptic® Active Ingredient*
Sore Throat
Phenol
Oral Anesthetic Spray
Instant Relif of:
- Sore throat
- Mouth irritation
Cherry Flavor
Alcohol 0.10%
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED WRAP AROUND THE CAP IS BROKEN OR TORN.
Distributed by:
Wal-Mart Stores, Inc.,
Bentonville, AR 72716
*This product is not manufactured or distributed by Prestige Brands, inc., owner of the registered trademark Chloraseptic®.
Package Label
Equate Sore Throat Spray
* Please review the disclaimer below.
