Otc - Purpose
| Active Ingredients | Purposes |
| Phenol 1.4% | Oral Anesthetic/ Analgesic |
Nice Sore Throat Cherry Spray
FDA Label NDC 69626-0047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leosons Overseas Corp for the product Nice Sore Throat Cherry (NDC 69626-0047). 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 otc - purpose, uses, warnings, otc - when using, stop use and ask a doctor if, if pregnant or breast feeding,, keep this and all drugs out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.
Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
Otc - When Using
When using this product do not use more than directed.
Stop Use And Ask A Doctor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- difficulty in breathing occurs
If Pregnant Or Breast Feeding,
- ask a health professional before use.
Keep This And All Drugs Out Of Reach Of Children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.
Directions
- apply to the affected area
- allow to remain in place for at least 15 seconds, then spit out
- use every 2 hours or as directed by a doctor or dentist
| age | dose |
| adults and children 12 years of age and older | for each application, spray 5 times |
| children 3 to under 12 years | should be supervised in use of this product; for each application, spray 3 times |
| children under 3 years of age | consult a doctor or dentist |
Other Information
- store at room temperature
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.
Inactive Ingredients
citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, sodium saccharin, and water.
Questions?
1-855-452-9500 or email at [email protected]
Distributed By:
LEOSONS
Albany, New York 12205
MADE IN THE USA
Principal Display Panel
- Sugar Free
- Alcohol Free
- Aspirin Free
N'ICE®
PHENOL/ ORAL ANESTHETIC
Sore Throat Spray
Fast acting, long lasting relief of minor sore throat and mouth pain
Cherry Flavor
6 FL OZ (177 mL)
* Please review the disclaimer below.
