Active Ingredient
Phenol 1.4%
Sore Throat Spray
FDA Label NDC 49035-376
14 label sections · Submitted to the FDA by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) · 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 dentist or 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
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.
When Using This Product,
do not exceed recommended dose.
Stop Use And Ask A Dentist Or Doctor If
- sore throat is severe, or lasts for more than 2 days
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- fever, headache, rash, swelling, nausea or vomiting develops
If Pregnant Or Breast-Feeding,
ask a health professional 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 (1-800-222-1222) right away.
Directions
- adults and children 2 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 between 20°-25°C (68°-77°F). Do not refrigerate.
Inactive Ingredients
alcohol, FD&C red #40, flavor, glycerin, purified water, saccharin sodium anhydrous
Questions Or Comments?
Call 1-888-287-1915
Principal Display Panel
Compare to Chloraseptic® active ingredient*
Sore Throat Spray
Phenol 1.4%
Oral Anesthetic / Analgesic Spray
Relieves sore throat
- Aspirin free
- Sugar Free
For ages 2 years and older
Cherry Flavor
0.10% ALCOHOL
FL OZ (mL)
*This product is not manufactured or distributed by Prestige Consumer healthcare, Inc., distributor of Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS BROKEN OR MISSING. FOR LOT AND EXPIRATION DATE, SEE BOTTOM OF BOTTLE KEEP CAP ON WHEN NOT IN USE
Distributed by:
Walmart Inc.,
Bentonville, AR 72716
Package Label
EQUATE Sore Throat Spray Cherry Flavor
* Please review the disclaimer below.
