Active Ingredient
Phenol 1.4%
Quality Choice Spray
FDA Label NDC 83324-275
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Quality Choice (NDC 83324-275). 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 pain reliever
Uses
For the temporarily relief of occasional minor irritation, pain, sore mouth and sore throat.
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 6 years of age unless directed by a doctor.
When Using This Product,
do not exceed recommended dosage.
Stop Use And Ask A Dentist Or 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 doctor 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 right away at 1-800-222-1222.
Directions
- Adults and children 12 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 6 years to 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 room temperature.
- Check expiration date before using.
Inactive Ingredients
FD&C Red No. 40, flavor, glycerin, purified water, sucralose.
Questions Or Comments?
1-866-467-2748
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QUALITY CHOICE®
*Compare to the active ingredient chloraseptic®
NDC# 83324-275-06
Sore Throat Spray
Phenol/Oral Pain Reliever
Fast Acting
Numbs on Contact
Sugar-Free
Aspirin-Free
Natural Cherry Flavor
6 FL OZ (177 mL)
100% SATISFACTION GUARANTEED
*This product is not manufactured or distributed by Prestige Brands Inc., owner of registered trademark Chloraseptic®.
Tamper - Evident: Do not use if imprinted shrink band is broken or missing
Distributed by CDMA, Inc
Novi, MI 48375
Questions: 800-935-236
* Please review the disclaimer below.
