Ohm Sleep Well

Ohm Sleep Well
SPL v4
SPL
SPL Set ID 9cac0195-8dca-4c53-891c-d834f7479e30
Route
ORAL
Published
Effective Date 2019-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (4 [hp_X]) Arabica Coffee Bean (30 [hp_C]) Strychnos Ignatii Seed (12 [hp_C]) Strychnos Nux-vomica Seed Passiflora Incarnata Flowering Top Datura Stramonium Valerian
Inactive Ingredients
Alcohol Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-04-21

Description

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Avena Sativa 4X, Coffea Cruda 30C, Ignatia Amara 12C, Nux Vomica 30C, Passiflora Incarnata 4X, Stramonium 30C, Valeriana Officinalis 4X. *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.


Medication Information

Warnings and Precautions

WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

Indications and Usage

USES: Temporarily relieves sleeplessness and simple insomnia due to restless mind and nightmares.**

​**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and Administration

DIRECTIONS: Shake 10 times before use. Adults & children above 12 years: spray 3 times under the tongue 2 times before bedtime and during night as needed or as directed by a health care professional. Children under 12: use half the adult dose.

Description

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Avena Sativa 4X, Coffea Cruda 30C, Ignatia Amara 12C, Nux Vomica 30C, Passiflora Incarnata 4X, Stramonium 30C, Valeriana Officinalis 4X. *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 50565-1
  • ​KEEP OUT OF REACH OF CHILDREN.
Section 51727-6

INACTIVE INGREDIENTS: Ethanol Alcohol 15% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water, Vegetable Glycerin 15%

Section 51945-4

HOMEOPATHIC MEDICINE

NDC: 66096-727-05

SLEEP Well

Natural - Safe - Effective

No Side Effects

2 fl oz (59mL) / 15% Alcohol

PRODUCT OF USA

Section 53413-1

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1

Insomnia

Section 55106-9

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Avena Sativa 4X, Coffea Cruda 30C, Ignatia Amara 12C, Nux Vomica 30C, Passiflora Incarnata 4X, Stramonium 30C, Valeriana Officinalis 4X.

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 60561-8

Do not use if cap seal is broken.


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves sleeplessness and simple insomnia due to restless mind and nightmares.**

​**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and Administration (34068-7)

DIRECTIONS: Shake 10 times before use. Adults & children above 12 years: spray 3 times under the tongue 2 times before bedtime and during night as needed or as directed by a health care professional. Children under 12: use half the adult dose.

Warnings and Precautions (34071-1)

WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

Section 50565-1 (50565-1)
  • ​KEEP OUT OF REACH OF CHILDREN.
Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethanol Alcohol 15% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water, Vegetable Glycerin 15%

Section 51945-4 (51945-4)

HOMEOPATHIC MEDICINE

NDC: 66096-727-05

SLEEP Well

Natural - Safe - Effective

No Side Effects

2 fl oz (59mL) / 15% Alcohol

PRODUCT OF USA

Section 53413-1 (53413-1)

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com

Section 55105-1 (55105-1)

Insomnia

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Avena Sativa 4X, Coffea Cruda 30C, Ignatia Amara 12C, Nux Vomica 30C, Passiflora Incarnata 4X, Stramonium 30C, Valeriana Officinalis 4X.

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 60561-8 (60561-8)

Do not use if cap seal is broken.


Advanced Ingredient Data


Raw Label Data

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