SPL v3
SPL
SPL Set ID fb8c8d6d-3c7a-459d-97a8-d9094f3d546c
Route
ORAL
Published
Effective Date 2022-09-29
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 Caramel Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-01

Description

ASAFOETIDA (ASAFETIDA) 8 [hp-X] IGNATIA AMARA (IGNATUS BEAN)                        8 [hp-X] VALERIANA OFFICINALIS (VALERIAN)                8 [hp-X] AVENA SATIVA (OAT)                                                 8 [hp-X] ARGENTUM NITRICUM (SILVER NITRATE)          8 [hp-X] HYOSCYAMUS NIGER (HENBANE)                        8 [hp-X] PAEONIA OFFICINALIS (PEONY)                             8 [hp-X] STRAMONIUM (THORN APPLE)                               8 [hp-X] ANCOCCULUS INDICUS (INDIAN BERRY)             8 [hp-X] The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States.

Purpose

ASAFOETIDA                                  Restlessness and Anxiety IGNATIA AMARA                            Nervousness VALERIANA OFFICINALIS                Agitation AVENA SATIVA                              Sleeplessness ARGENTUM NITRICUM                   Nervousness ARGENTUM NITRICUM                   Nervousness HYOSCYAMUS NIGER                    Anguish and fear PAEONIA OFFICINALIS                 Apprehension, anxiety and irritability STRAMONIUM                             Nightmares and nervousness COCCULUS INDICUS                    Lack of concentration


Medication Information

Purpose

ASAFOETIDA                                  Restlessness and Anxiety

IGNATIA AMARA                            Nervousness

VALERIANA OFFICINALIS                Agitation

AVENA SATIVA                              Sleeplessness

ARGENTUM NITRICUM                   Nervousness

ARGENTUM NITRICUM                   Nervousness

HYOSCYAMUS NIGER                    Anguish and fear

PAEONIA OFFICINALIS                 Apprehension, anxiety and irritability

STRAMONIUM                             Nightmares and nervousness

COCCULUS INDICUS                    Lack of concentration

Description

ASAFOETIDA (ASAFETIDA) 8 [hp-X] IGNATIA AMARA (IGNATUS BEAN)                        8 [hp-X] VALERIANA OFFICINALIS (VALERIAN)                8 [hp-X] AVENA SATIVA (OAT)                                                 8 [hp-X] ARGENTUM NITRICUM (SILVER NITRATE)          8 [hp-X] HYOSCYAMUS NIGER (HENBANE)                        8 [hp-X] PAEONIA OFFICINALIS (PEONY)                             8 [hp-X] STRAMONIUM (THORN APPLE)                               8 [hp-X] ANCOCCULUS INDICUS (INDIAN BERRY)             8 [hp-X] The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States.

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of*: restlessness, nervousness, irritability, agitation, sleeplessness, lessen nightmares.

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

Section 50565-1

Warnings

Stop use and ask a doctor if symptoms worsen:

If you are pregnant or breast feeding, ask a health professional before.

Keep out of reach of children. In case of accidental overdose, contact a medical

professional or poison control center immediately.

Directions

• Do not exceed recommended dosage

• Repeat every 6 hours and reduce with improvement or as directed by a health professional.

Age………………………………………………………….................Dose

Adults and Children 12 + years. ............................................10 ml or 2 teaspoon (tsp)

Children 6 to 11 years of age. ...............................................5 ml or 1 teaspoon (tsp)

Children 2 to 5 years of age. .................................................2.5 ml or ½ teaspoon (tsp)

Product Label

Other Information

Store at room temperature.• Do not use if seal is broken or missing

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

Active Ingredients

ASAFOETIDA (ASAFETIDA) 8 [hp-X]

IGNATIA AMARA (IGNATUS BEAN)                        8 [hp-X]

VALERIANA OFFICINALIS (VALERIAN)                8 [hp-X]

AVENA SATIVA (OAT)                                                 8 [hp-X]

ARGENTUM NITRICUM (SILVER NITRATE)          8 [hp-X]

HYOSCYAMUS NIGER (HENBANE)                        8 [hp-X]

PAEONIA OFFICINALIS (PEONY)                             8 [hp-X]

STRAMONIUM (THORN APPLE)                               8 [hp-X]

ANCOCCULUS INDICUS (INDIAN BERRY)             8 [hp-X]

The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States.

Inactive Ingredients

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.


Structured Label Content

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of*: restlessness, nervousness, irritability, agitation, sleeplessness, lessen nightmares.

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

Section 50565-1 (50565-1)

Purpose

ASAFOETIDA                                  Restlessness and Anxiety

IGNATIA AMARA                            Nervousness

VALERIANA OFFICINALIS                Agitation

AVENA SATIVA                              Sleeplessness

ARGENTUM NITRICUM                   Nervousness

ARGENTUM NITRICUM                   Nervousness

HYOSCYAMUS NIGER                    Anguish and fear

PAEONIA OFFICINALIS                 Apprehension, anxiety and irritability

STRAMONIUM                             Nightmares and nervousness

COCCULUS INDICUS                    Lack of concentration

Warnings

Stop use and ask a doctor if symptoms worsen:

If you are pregnant or breast feeding, ask a health professional before.

Keep out of reach of children. In case of accidental overdose, contact a medical

professional or poison control center immediately.

Directions

• Do not exceed recommended dosage

• Repeat every 6 hours and reduce with improvement or as directed by a health professional.

Age………………………………………………………….................Dose

Adults and Children 12 + years. ............................................10 ml or 2 teaspoon (tsp)

Children 6 to 11 years of age. ...............................................5 ml or 1 teaspoon (tsp)

Children 2 to 5 years of age. .................................................2.5 ml or ½ teaspoon (tsp)

Product Label (Product label)

Other Information (Other information)

Store at room temperature.• Do not use if seal is broken or missing

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

Active Ingredients

ASAFOETIDA (ASAFETIDA) 8 [hp-X]

IGNATIA AMARA (IGNATUS BEAN)                        8 [hp-X]

VALERIANA OFFICINALIS (VALERIAN)                8 [hp-X]

AVENA SATIVA (OAT)                                                 8 [hp-X]

ARGENTUM NITRICUM (SILVER NITRATE)          8 [hp-X]

HYOSCYAMUS NIGER (HENBANE)                        8 [hp-X]

PAEONIA OFFICINALIS (PEONY)                             8 [hp-X]

STRAMONIUM (THORN APPLE)                               8 [hp-X]

ANCOCCULUS INDICUS (INDIAN BERRY)             8 [hp-X]

The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States.

Inactive Ingredients (Inactive ingredients)

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)