Sore Throat Cherry Liquid
FDA Label NDC 0904-6305

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Sore Throat Cherry (NDC 0904-6305). 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(s), purpose, use(s), warnings, when using this product, stop use and ask 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

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ When Using This Product

→ Stop Use And Ask Doctor If

→ If Pregnant Or Breast Feeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient(S)

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Use(S)

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 occurs with high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not sue more than 2 days or administer to children under 6 years of age unless directed by doctor.

When Using This Product

Do not exceed recommended dosage.

Stop Use And Ask Doctor If

irritation, pain or redness persists or worsens
sore mouth symptoms do not improve in 7 days
swelling, rash or fever develops

If Pregnant Or Breast Feeding

ask a doctor before use.

Keep Out Of Reach Of Children

Keep this and all drugs out of the 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

Adults and children 6 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 should be supervised in the use of this product.

Children under 6 years of age: Consult a doctor or dentist.