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SPL v3

SPL

SPL Set ID ce7273d4-01f8-4b6b-b33a-83bd2d4fb07a

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 : Asafoetida 8X Ignatia amara 8X Valeriana officinalis 8X Avena sativa 8X Argentum nitricum 8X Hyoscyamus niger 8X Paeonia officinalis 8X Stramonium 8X Cocculus indicus 8X

Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if symptoms 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 : Asafoetida 8X Ignatia amara 8X Valeriana officinalis 8X Avena sativa 8X Argentum nitricum 8X Hyoscyamus niger 8X Paeonia officinalis 8X Stramonium 8X Cocculus indicus 8X

Section 44425-7

Other information

•Store at room temperature

•Do not use if 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:

Asafoetida 8X..............................restlessness and anxiety

Ignatia amara 8X.........................nervousness

Valeriana officinalis 8X..................agitation

Avena sativa 8X...........................sleeplessness

Argentum nitricum 8X...................nervousness

Hyoscyamus niger 8X...................anguish and fear

Paeonia officinalis 8X....................apprehension, anxiety and irritability

Stramonium 8X............................nightmares and nervousness

Cocculus indicus 8X......................lack of concentration

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

Homeopathic Pharmacopoeia of the United States.

Section 55106-9

Active Ingredients HPUS:

Asafoetida 8X

Ignatia amara 8X

Valeriana officinalis 8X

Avena sativa 8X

Argentum nitricum 8X

Hyoscyamus niger 8X

Paeonia officinalis 8X

Stramonium 8X

Cocculus indicus 8X

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 if symptoms worsen.

Section 44425-7 (44425-7)

Other information

•Store at room temperature

•Do not use if 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:

Asafoetida 8X..............................restlessness and anxiety

Ignatia amara 8X.........................nervousness

Valeriana officinalis 8X..................agitation

Avena sativa 8X...........................sleeplessness

Argentum nitricum 8X...................nervousness

Hyoscyamus niger 8X...................anguish and fear

Paeonia officinalis 8X....................apprehension, anxiety and irritability

Stramonium 8X............................nightmares and nervousness

Cocculus indicus 8X......................lack of concentration

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

Homeopathic Pharmacopoeia of the United States.

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Asafoetida 8X

Ignatia amara 8X

Valeriana officinalis 8X

Avena sativa 8X

Argentum nitricum 8X

Hyoscyamus niger 8X

Paeonia officinalis 8X

Stramonium 8X

Cocculus indicus 8X

Advanced Ingredient Data

[{"name": "ASAFETIDA", "unii": "W9FZA51AS1", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "VALERIANA OFFICINALIS WHOLE", "unii": "FP6O7F1X9R", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "OAT BRAN", "unii": "KQX236OK4U", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SILVER CATION", "unii": "57N7B0K90A", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "HYOSCYAMUS NIGER", "unii": "4WRK2153H3", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PAEONIA OFFICINALIS ROOT", "unii": "8R564U2E1P", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "DATURA STRAMONIUM", "unii": "G6W4F0V8Z3", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ANAMIRTA COCCULUS WHOLE", "unii": "8O4P2U3QO2", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "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.", "34071-1": "Warnings Stop use and ask a doctor if symptoms worsen. ", "44425-7": "Other information •Store at room temperature • Do not use if seal is broken or missing", "50565-1": "Keep out of reach of children . In case of accidental overdose, contact a medical professional or a poison control center immediately. ", "51727-6": "Inactive ingredients Purified water, sorbitol, grape and rapsberry flavor, sodium benzoate, potassium sorbate, citric acid.", "55105-1": "Purpose of the Drug : Asafoetida 8X..............................restlessness and anxiety Ignatia amara 8X.........................nervousness Valeriana officinalis 8X..................agitation Avena sativa 8X...........................sleeplessness Argentum nitricum 8X...................nervousness Hyoscyamus niger 8X...................anguish and fear Paeonia officinalis 8X....................apprehension, anxiety and irritability Stramonium 8X............................nightmares and nervousness Cocculus indicus 8X......................lack of concentration The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.", "55106-9": "Active Ingredients HPUS : Asafoetida 8X Ignatia amara 8X Valeriana officinalis 8X Avena sativa 8X Argentum nitricum 8X Hyoscyamus niger 8X Paeonia officinalis 8X Stramonium 8X Cocculus indicus 8X"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:51.096284 · Updated: 2026-03-14T23:14:52.066875