OHM SLEEP WELL- avena sativa, coffea cruda, ignatia amara, nux vomica, passiflora, incarnata, stramonium, valeriana officinalis. liquid

OHM Sleep Well by

Drug Labeling and Warnings

OHM Sleep Well by is a Homeopathic medication manufactured, distributed, or labeled by OHM PHARMA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

INDICATIONS & 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.

WARNINGS

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.

• ​KEEP OUT OF REACH OF CHILDREN.

DOSAGE & 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.

OTHER SAFETY INFORMATION

Do not use if cap seal is broken.

INACTIVE INGREDIENT

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

QUESTIONS

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

www.ohmpharma.com

PRINCIPAL DISPLAY PANEL

HOMEOPATHIC MEDICINE

NDC: 66096-727-05

SLEEP Well

Natural - Safe - Effective

No Side Effects

2 fl oz (59mL) / 15% Alcohol

PRODUCT OF USA

Insomnia

INGREDIENTS AND APPEARANCE

OHM SLEEP WELL 
avena sativa, coffea cruda, ignatia amara, nux vomica, passiflora, incarnata, stramonium, valeriana officinalis. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66096-727
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	4 [hp_X]  in 59 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	30 [hp_C]  in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_C]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C]  in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	4 [hp_X]  in 59 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	30 [hp_C]  in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	4 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66096-727-05	59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/21/2017

Labeler - OHM PHARMA INC. (030572478)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(66096-727)