Herbion Naturals Orange
FDA Label NDC 44237-015

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 (NDC 44237-015). 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, ask a doctor before use if you have, stop use and ask a doctor if, otc - keep out of reach of children, directions, 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, 5.5mg

Purpose

Cough suppressant / Oral Anesthetic

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

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)

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.

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

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 Ingredients

Ascorbic Acid, Artificial Flavors, 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.

Questions Or Comments?


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

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

Made in Pakistan


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Herbion Naturals

Relieves Cough and Soothes Sore Throat

NATURAL CARE

cough drops

Menthol

-Cough suppressant            Orange
-Oral anesthetic                  18 Drops

Orange Lozenge Carton (Orangelabel)

Orange Lozenge Carton (Orangelabel)


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