Diabetic Tussin Sore Throat Cherry Spray
FDA Label NDC 61787-066

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc for the product Diabetic Tussin Sore Throat Cherry (NDC 61787-066). 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

Active Ingredient

Phenol 1.4%

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 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 12 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 health care 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 12 years of age and older:

  • Apply to the affected area (one spray).
  • 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.

    • Children under 12 years of age: ask a doctor before use.

Other Information

  • store between 20°-25°C (68-°77°F). 
  • do not refrigerate.

Inactive Ingredients

alcohol, FD&C red #40, flavors, glycerin, purified water, sodium saccharin anhydrous

Questions?

1-800-579-8327

Principal Display Panel

Diabetic Tussin®
Phenol / Oral Pain Reliever
Cherry
6 fl oz (177 mL) SPRAY

Diabetic Tussin®phenol / Oral Pain Reliever Cherry6 Fl Oz (177 mL) Spray (Diabetic Tussin Sore Throat Cherry Spray 01)

Diabetic Tussin®phenol / Oral Pain Reliever Cherry6 Fl Oz (177 mL) Spray (Diabetic Tussin Sore Throat Cherry Spray 01)

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