valerianaheel oral drop

valerianaheel oral drop
SPL v1
SPL
SPL Set ID 89c84354-e423-415c-bb31-dba20e4cc95f
Route
oral
Published
Effective Date 2012-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
valerian (2 [hp_X]) trinitrophenol (6 [hp_X]) prunus spinosa flower bud (3 [hp_X]) hops (2 mm) hypericum perforatum melissa officinalis avena sativa flowering top matricaria recutita ammonium bromide potassium cation bromide ion
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 1986-01-31

Indications and Usage

For the temporary relief of: Sleeplessness Restlessness Nervous tension and exhaustion

Dosage and Administration

Adults and children above 11 years: 10 drops orally, 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.

Purpose

Sleeplessness, Restlessness, Nervous tension and exhaustion

Description

Keep this and all medicines out of the reach of children.


Medication Information

Warnings
If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.
Indications and Usage
For the temporary relief of:

  • Sleeplessness
  • Restlessness
  • Nervous tension and exhaustion





Purpose
Sleeplessness, Restlessness, Nervous tension and exhaustion

Dosage and Administration
Adults and children above 11 years: 10 drops orally, 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.
Description

Keep this and all medicines out of the reach of children.

Section 51945-4






Active Ingredient
Each 50 ml contains as active ingredients: Valeriana officinalis 2X 32.5 ml; Picricum acidum 6X 5 ml; Prunus spinosa 2X 2.5 ml; Humulus lupulus 2X 2.5 ml; Hypericum perforatum 3X 2.5 ml; Melissa officinalis 2X 1.5 ml; Avena sativa 2X 1 ml; Chamomilla 2X 1 ml; Ammonium bromatum 2X 0.5 ml; Kali bromatum 2X 0.5 ml; Natrum bromatum 2X 0.5 ml.

Inactive Ingredient
Inactive ingredients: Ethanol, Purified Water USP.

Keep Out of Reach of Children
Keep this and all medicines out of the reach of children.

Structured Label Content

Warnings (WARNINGS)
If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.
Indications and Usage (INDICATIONS AND USAGE)
For the temporary relief of:

  • Sleeplessness
  • Restlessness
  • Nervous tension and exhaustion





Purpose (PURPOSE)
Sleeplessness, Restlessness, Nervous tension and exhaustion

Dosage and Administration (DOSAGE AND ADMINISTRATION)
Adults and children above 11 years: 10 drops orally, 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.
Section 51945-4 (51945-4)






Active Ingredient (ACTIVE INGREDIENT)
Each 50 ml contains as active ingredients: Valeriana officinalis 2X 32.5 ml; Picricum acidum 6X 5 ml; Prunus spinosa 2X 2.5 ml; Humulus lupulus 2X 2.5 ml; Hypericum perforatum 3X 2.5 ml; Melissa officinalis 2X 1.5 ml; Avena sativa 2X 1 ml; Chamomilla 2X 1 ml; Ammonium bromatum 2X 0.5 ml; Kali bromatum 2X 0.5 ml; Natrum bromatum 2X 0.5 ml.

Inactive Ingredient (INACTIVE INGREDIENT)
Inactive ingredients: Ethanol, Purified Water USP.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)
Keep this and all medicines out of the reach of children.

Advanced Ingredient Data


Raw Label Data

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