SPL v2
SPL
SPL Set ID 5f80af07-ea8c-496f-ae5d-179c01e50c63
Route
ORAL
Published
Effective Date 2012-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.6 mg)
Inactive Ingredients
Ascorbic Acid Citric Acid Monohydrate Eucalyptus Oil Hyssopus Officinalis Flowering Top Lesser Galangal Root Licorice Long Pepper Justicia Adhatoda Leaf Sucrose Viola Odorata Leaf Water

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: brown Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-01

Description

Menthol, 1.6 mg

Purpose

Cough Suppresant, Oral Anesthetic


Medication Information

Purpose

Cough Suppresant, Oral Anesthetic

Description

Menthol, 1.6 mg

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

Section 50565-1
  • Keep this and all drugs out of the reach of children.

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.

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.              

               
Side Panel:

Manufactured for:

Herbion USA Inc.

Williamsville, NY 14221

1-888-(OK-HERBION)-654-3724

[email protected]

www.herbion.com

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, Honey-Lemon 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

Principal Display Panel:

Herbion Naturals

Relieves Cough and Soothes Sore Throat

All Natural

Cough Drops

Herbal Formula

Honey Lemon

18 Drops

Active Ingredient (in Each Drop)

Menthol, 1.6 mg


Structured Label Content

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

Section 50565-1 (50565-1)
  • Keep this and all drugs out of the reach of children.

Purpose

Cough Suppresant, Oral Anesthetic

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.

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.              

               
Side Panel:

Manufactured for:

Herbion USA Inc.

Williamsville, NY 14221

1-888-(OK-HERBION)-654-3724

[email protected]

www.herbion.com

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, Honey-Lemon 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

Principal Display Panel:

Herbion Naturals

Relieves Cough and Soothes Sore Throat

All Natural

Cough Drops

Herbal Formula

Honey Lemon

18 Drops

Active Ingredient (in Each Drop) (Active Ingredient (in each drop))

Menthol, 1.6 mg


Advanced Ingredient Data


Raw Label Data

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