SPL v9
SPL
SPL Set ID fdc34e7c-1611-4aa0-a93a-7123644767a0
Route
ORAL
Published
Effective Date 2018-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Asafetida (8 [hp_X]) Strychnos Ignatii Seed Valeriana Officinalis Whole Oat Bran Silver Cation Hyoscyamus Niger Paeonia Officinalis Root Datura Stramonium Anamirta Cocculus Whole
Inactive Ingredients
Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-03-03

Description

Active Ingredients HPUS : Asafo etida (Asafetida) 8 [HP_ X] in 100 mL. Ignatia amara (Ig natius bean) 8 [ HP_X] in 100 mL. Valeriana officinalis (Valerian) 8 [HP_ X] in a 100 mL. Avena sativa (Oats) 8 [HP_X] in a 100 mL. Argentum nitricum (Silver nitrate) 8 [HP_X] in a 100 mL. Hyoscyamus niger (Henbane) 8 [HP_ X] in a 100 mL. Paeonia officinalis (Peony) 8 [ HP_ X] in a 100 ml Stramonium (Thorn apple) 8 [HP_ X] in a 100 mL. Cocculus indicus (Indian berry) 8


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor ifsymptoms worsen. 

Indications and Usage

•Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:

•Restlessness  •nervousness  •irritability 

•agitation  •sleeplessness   lessens nightmares

Dosage and Administration

Directions •Children under 6 months of age: Consult a 

licensed healthcare practitioner before using this product

•Children 6 months to 2 years old: 2.5 ml or 1.2 teaspoon,

every 6 hours or 4 times a day •Children 2 to 12 years old:

5ml or 1 teaspoon, every 6 hours or 4 times a day.

Description

Active Ingredients HPUS : Asafo etida (Asafetida) 8 [HP_ X] in 100 mL. Ignatia amara (Ig natius bean) 8 [ HP_X] in 100 mL. Valeriana officinalis (Valerian) 8 [HP_ X] in a 100 mL. Avena sativa (Oats) 8 [HP_X] in a 100 mL. Argentum nitricum (Silver nitrate) 8 [HP_X] in a 100 mL. Hyoscyamus niger (Henbane) 8 [HP_ X] in a 100 mL. Paeonia officinalis (Peony) 8 [ HP_ X] in a 100 ml Stramonium (Thorn apple) 8 [HP_ X] in a 100 mL. Cocculus indicus (Indian berry) 8

Section 44425-7

Other information

•Store at room temperature

Do not useif seal is broken or missing

Section 50565-1

Keep out of reach of children. In case of accidental

overdose, contact a medical professional or a poison

control center immediately. 

Section 51727-6

Inactive ingredients

Purified water, sorbitol, grape and rapsberry flavor,

sodium benzoate, potassium sorbate, citric acid.

Section 51945-4

Section 55105-1

Purpose of the Drug:

[e.g. sunscreen, analgesic, etc.] Purpose

Restlessness and anxiety

Nervousness. Agitation

Sleeplessness Anguish and fear

Apprehension, anxiety and irritability

Nightmares and nervousness

Lack of concentration

The letters 'HPUS' indicate that the components in this product are officially monographed in the

Homeopathic Pharmacopoeia of the United States.

*These claims have not been reviewed or evalauted by the Food and Drug Administration. They are based on traditional homeopathic practice not

medical evidence.

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:

Restlessness, nervousness, irritability, agitation, sleeplessness, lessens nightmares

Section 55106-9

Active Ingredients HPUS:

Asafo etida (Asafetida) 8 [HP_ X] in 100 mL.

Ignatia amara (Ig natius bean) 8 [ HP_X] in 100 mL.

Valeriana officinalis (Valerian) 8 [HP_ X] in a 100 mL.

Avena sativa (Oats) 8 [HP_X] in a 100 mL.

Argentum nitricum (Silver nitrate) 8 [HP_X] in a 100 mL.

Hyoscyamus niger (Henbane) 8 [HP_ X] in a 100 mL.

Paeonia officinalis (Peony) 8 [ HP_ X] in a 100 ml

Stramonium (Thorn apple) 8 [HP_ X] in a 100 mL.

Cocculus indicus (Indian berry) 8


Structured Label Content

Indications and Usage (34067-9)

•Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:

•Restlessness  •nervousness  •irritability 

•agitation  •sleeplessness   lessens nightmares

Dosage and Administration (34068-7)

Directions •Children under 6 months of age: Consult a 

licensed healthcare practitioner before using this product

•Children 6 months to 2 years old: 2.5 ml or 1.2 teaspoon,

every 6 hours or 4 times a day •Children 2 to 12 years old:

5ml or 1 teaspoon, every 6 hours or 4 times a day.

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor ifsymptoms worsen. 

Section 44425-7 (44425-7)

Other information

•Store at room temperature

Do not useif seal is broken or missing

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental

overdose, contact a medical professional or a poison

control center immediately. 

Section 51727-6 (51727-6)

Inactive ingredients

Purified water, sorbitol, grape and rapsberry flavor,

sodium benzoate, potassium sorbate, citric acid.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose of the Drug:

[e.g. sunscreen, analgesic, etc.] Purpose

Restlessness and anxiety

Nervousness. Agitation

Sleeplessness Anguish and fear

Apprehension, anxiety and irritability

Nightmares and nervousness

Lack of concentration

The letters 'HPUS' indicate that the components in this product are officially monographed in the

Homeopathic Pharmacopoeia of the United States.

*These claims have not been reviewed or evalauted by the Food and Drug Administration. They are based on traditional homeopathic practice not

medical evidence.

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of:

Restlessness, nervousness, irritability, agitation, sleeplessness, lessens nightmares

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Asafo etida (Asafetida) 8 [HP_ X] in 100 mL.

Ignatia amara (Ig natius bean) 8 [ HP_X] in 100 mL.

Valeriana officinalis (Valerian) 8 [HP_ X] in a 100 mL.

Avena sativa (Oats) 8 [HP_X] in a 100 mL.

Argentum nitricum (Silver nitrate) 8 [HP_X] in a 100 mL.

Hyoscyamus niger (Henbane) 8 [HP_ X] in a 100 mL.

Paeonia officinalis (Peony) 8 [ HP_ X] in a 100 ml

Stramonium (Thorn apple) 8 [HP_ X] in a 100 mL.

Cocculus indicus (Indian berry) 8


Advanced Ingredient Data


Raw Label Data

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