Active Ingredient
Phenol 1.4%
Sore Throat Spray
FDA Label NDC 55319-376
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Sore Throat (NDC 55319-376). 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
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. 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 Dentist Or Doctor If
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
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
- 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 between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
alcohol, FD&C red #40, glycerin, flavor, purified water, saccharin sodium
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN CHLORASEPTIC®*
Sore Throat Spray
Phenol/Oral Anesthetic
- Relieves Sore Throat
- Aspirin Free
- Sugar Free
- Alcohol 0.10%
CHERRY
FL OZ (mL)
*This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Chloraseptic®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD,
MATTHEWS, NC 28105
Package Label
FAMILY WELLNESS Sore throat Spray Cherry Flavor
* Please review the disclaimer below.
