Herbion Naturals
FDA Label NDC 44237-010

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 (NDC 44237-010). 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 (in each drop), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Drop)

Menthol, 5 mg

Purpose

Cough Suppresant, Oral Anesthetic

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold.

Warnings

  • A persistent cough may be a sign of a serious condition.  If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • If breast-feeding or pregnant, consult your physician before using.

Otc - Keep Out Of Reach Of Children

  • Keep this and all drugs out of the reach of children.

Directions

          
           
Adults and children 12 years and over: Take 1-2 drops every 2 to 3 hours.
Children 6 years to under 12 years: Take 1 drop every 5 to 6 hours not more than 4 drops in 24 hours
Children under 6 years of age:  Consult your doctor.



           
               

Other Information

  • Store in a cool, dry place, below 77 degrees F.
  • Protect from heat and light.
  • Diabetic patients should not use Herbion drops without the advice of physician and they should monitor glucose level closely while taking drops as it may alter blood-glucose levels.

Inactive Ingredients

Ascorbic Acid, Citric Acid, Eucalyptus Oil, Orange Flavor, Hyssop, Large-leaf Geiger Tree Fruit, Lesser Galangal Rhizome, Licorice Root, Long Pepper Fruit, Malabar Nut Leaf, Cane Sugar, Sweet Violet Leaf and Flower, Water

Side Panel:

Manufactured for:
Herbion USA Inc.
Williamsville, NY 14221
1-888-(OK-HERBION)-654-3724
[email protected]
www.herbion.com

Principal Display Panel:

Herbion Naturals

Relieves Cough and Soothes Sore Throat

All Natural

Cough Drops

Herbal Formula

Orange

18 Drops

Orange Drops Carton (Orangecarton)

Orange Drops Carton (Orangecarton)


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