d9047378-5d03-4ef5-98f9-3eb78840222c

Drug Facts

Composition & Product

Active Ingredients

passiflora incarnata flower (3 [hp_X]) strychnos ignatii seed valerian

Inactive Ingredients

water gelatin lactose magnesium stearate starch, potato sodium benzoate talc

Identifiers & Packaging

Pill Appearance

Imprint: NONE Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

unapproved homeopathic active Since 2010-12-23

Medication Information

Warnings and Precautions

Do not use

if you have an allergy or hypersensitivity to components of the formula

Active Ingredient

Ignatia amara 3X HPUS

Passiflora incarnata 3X HPUS

Valeriana officinalis 3X HPUS

Indications and Usage

For relief of symptoms of sleeplessness and stress as per homeopathic materia medica. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and poduct has not been clinically tested.

Dosage and Administration

Directions:

Adults and children over 12 years: take 2 tablets every 4 hours during the day. Dissolve slowly in the mouth.
Children under 12: Do not use.

Description

Ignatia amara 3X HPUS Passiflora incarnata 3X HPUS Valeriana officinalis 3X HPUS

Section 44425-7

store in a cool and dry place

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

discomfort persists
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

Section 51727-6

Gelatin, Lactose USP, Magnesium Stearate, Potato Starch, Purified water, Sodium Benzoate, Talc USP

Section 51945-4

NDC 34666-008-06

Homeopathic Simplex

Ignatia amara, Passiflora incaranata, Valeriana officinalis

Relieves symptoms of Sleeplessness and Stress

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Stress Control

Directions

2 tablets every 4 hours**

* Based on homeopathic materia medica

** See directions at the back

6 tablets

Section 53413-1

Questions or Comments?

[email protected]

1877 248 1970 between 9 am and 5 pm CST

Section 53414-9

If pregnant or breast feeding, consult a health professional before use.

Section 55105-1

Ignatia Amara 3X HPUS.....................Sleeplessnes, worry

Passiflora incarnata 3X HPUS.............Nervousness, sleeplessness

Valeriana oficinalis 3X HPUS..............Sleeplessness

Structured Label Content

Warnings and Precautions (34071-1)

Do not use

if you have an allergy or hypersensitivity to components of the formula

Active Ingredient (55106-9)

Ignatia amara 3X HPUS

Passiflora incarnata 3X HPUS

Valeriana officinalis 3X HPUS

Indications and Usage (34067-9)

For relief of symptoms of sleeplessness and stress as per homeopathic materia medica. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and poduct has not been clinically tested.

Dosage and Administration (34068-7)

Directions:

Adults and children over 12 years: take 2 tablets every 4 hours during the day. Dissolve slowly in the mouth.
Children under 12: Do not use.

Section 44425-7 (44425-7)

store in a cool and dry place

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

discomfort persists
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

Section 51727-6 (51727-6)

Gelatin, Lactose USP, Magnesium Stearate, Potato Starch, Purified water, Sodium Benzoate, Talc USP

Section 51945-4 (51945-4)

NDC 34666-008-06

Homeopathic Simplex

Ignatia amara, Passiflora incaranata, Valeriana officinalis

Relieves symptoms of Sleeplessness and Stress

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Stress Control

Directions

2 tablets every 4 hours**

* Based on homeopathic materia medica

** See directions at the back

6 tablets

Section 53413-1 (53413-1)

Questions or Comments?

[email protected]

1877 248 1970 between 9 am and 5 pm CST

Section 53414-9 (53414-9)

If pregnant or breast feeding, consult a health professional before use.

Section 55105-1 (55105-1)

Ignatia Amara 3X HPUS.....................Sleeplessnes, worry

Passiflora incarnata 3X HPUS.............Nervousness, sleeplessness

Valeriana oficinalis 3X HPUS..............Sleeplessness

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, POTATO", "unii": "8I089SAH3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PASSIFLORA INCARNATA FLOWER", "unii": "K8F3G29S6Z", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "VALERIAN", "unii": "JWF5YAW3QW", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For relief of symptoms of sleeplessness and stress as per homeopathic materia medica. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and poduct has not been clinically tested.", "34068-7": "Directions: Adults and children over 12 years: take 2 tablets every 4 hours during the day. Dissolve slowly in the mouth. Children under 12: Do not use.", "34071-1": "Do not use if you have an allergy or hypersensitivity to components of the formula", "44425-7": "store in a cool and dry place", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if discomfort persists sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness", "51727-6": "Gelatin, Lactose USP, Magnesium Stearate, Potato Starch, Purified water, Sodium Benzoate, Talc USP", "51945-4": "NDC 34666-008-06 Homeopathic Simplex Ignatia amara, Passiflora incaranata, Valeriana officinalis Relieves symptoms of Sleeplessness and Stress Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested. Stress Control Directions 2 tablets every 4 hours** * Based on homeopathic materia medica ** See directions at the back 6 tablets", "53413-1": "Questions or Comments? informacion@nartexlabs.com 1877 248 1970 between 9 am and 5 pm CST", "53414-9": "If pregnant or breast feeding , consult a health professional before use.", "55105-1": "Ignatia Amara 3X HPUS.....................Sleeplessnes, worry Passiflora incarnata 3X HPUS.............Nervousness, sleeplessness Valeriana oficinalis 3X HPUS..............Sleeplessness", "55106-9": "Ignatia amara 3X HPUS Passiflora incarnata 3X HPUS Valeriana officinalis 3X HPUS"}

d9047378-5d03-4ef5-98f9-3eb78840222c

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information