Sorepils Menthol Cough Suppressant And Oral Anesthetic Drops Honey Lemon Flavor Lozenge
FDA Label NDC 87303-001

12 label sections · Submitted to the FDA by Basic Supplement Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Basic Supplement Inc. for the product Sorepils Menthol Cough Suppressant And Oral Anesthetic Drops Honey Lemon Flavor (NDC 87303-001). 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 if, if pregnant or breast-feeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 7.6mg

Purpose

Cough Suppressant/Oral Anesthetic

Uses

  • for temporary relief of occasional minor irritation, pain, sore mouth, and sore throat
  • temporarily alleviates cough due to minor bronchial irritation as may occur with the common cold

Warnings

Sore Throat Warning:Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

When Using This Product

  • Do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • Sore mouth symptoms do not improve in 2 days, or if irritation, pain, or redness persists or worsens
  • Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
  • Cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • Cough is persistent or chronic such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus).

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

  • Adults and children 2 years of age and older: Dissolve 1 lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.
  • Children under 2 years of age: Consult a doctor.

Other Information

  • Excessive consumption may have a laxative effect.

Inactive Ingredients

Beta Carotene Color, Eucalyptus Oil, Honey Flavor, Isomalt, Lemon Flavor, Mint Flavor, Purified Water, Sucralose.

Question/Comments?:

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Package Labeling:

Sorepils Menthol Cough Suppressant and Oral Anesthetic Drops, Honey Lemon Flavor

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