Active Ingredient
Phenol 1.4%
Sore Throat Relief Spray
FDA Label NDC 70000-0458
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Sore Throat Relief (NDC 70000-0458). 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 or dentist 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 or administer to children under 6 years of age unless directed by a doctor.
When Using This Product,
do not exceed recommended dose.
Stop Use And Ask A Doctor Or Dentist 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.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out.
Adults and children 12 year of age and older | Use every 2 hours or as directed by a doctor or dentist |
Children under 12 years of age | Should be supervised in use of this product |
Children under 6 years of age | Ask 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
Principal Display Panel
NDC# 70000-0458-1
Sore Throat Spray
Phenol 1.4%
Oral Anesthetic / Analgesic
Cherry Flavor
Sore Throat Relief
Sugar-Free
6 FL. OZ. (177 mL)
100% Money Back Guarantee
Return to place of purchase.
Aspirin-Free
COMPARE TO CHLORASEPTIC® active ingredient*
TAMPER EVIDENT: Do not use if imprinted shrink band is broken or missing.
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Chloraseptic®.
©2018 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademark or registered trademarks of Cardinal Health.
www.myleader.com 1-800-200-6313
Leader Cherry Flavor Sore Throat Phenol 1.4% (Image 01)
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