Herbion Naturals Orange Cough Drops
FDA Label NDC 44237-024

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Herbion Pakistan (pvt.) Ltd for the product Herbion Naturals Orange Cough Drops (NDC 44237-024). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each drop):

Menthol, 5.5mg

Otc - Purpose

Purpose:

Cough suppressant / Oral Anesthetic

Indications & Usage

Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • for temporary relief of occasional minor irritation, pain, sore mouth and sore throat

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.These may be serious

Otc - Ask Doctor

Ask a doctor before use if you have:

  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that is accompanied by excessive phlegm (mucus)

Otc - Do Not Use

Stop use and ask a doctor if:

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition
  • sore mouth does not improve in 7 days
  • irritation, pain or redness persists or worsens

Otc - Keep Out Of Reach Of Children

keep out of reach of children

Dosage & Administration

Directions:

  • adults and children 2 years of age and over Dissolve 1 drop slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor
  • children under 2 years of age: consult a physician

General Precautions

Other Information:

  • diabetic patients should not use Herbion drops without the advice of a physician and they should monitor glucose levels closely while taking drops as they may alter blood-glucose levels
  • store in a cool, dry place, below 77°F
  • protect from heat and light

Inactive Ingredient

Inactive Ingredients:

Ascorbic Acid, Natural orange flavor, Cane sugar, Citric acid, Eucalyptus oil, Greater galangal Rhizome, Hyssop, Large-leaf geiger tree Fruit, Licorice Root, Liquid glucose, Long pepper Fruit, Malabar nut tree Leaf

Otc - Questions

Questions or Comments?

1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5am

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