OHM Sleep Well

AVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, NUX VOMICA, PASSIFLORA, INCARNATA, STRAMONIUM, VALERIANA OFFICINALIS. ORAL HUMAN OTC DRUG

OHM Sleep Well is an FDA drug label for the active ingredient AVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, NUX VOMICA, PASSIFLORA, INCARNATA, STRAMONIUM, VALERIANA OFFICINALIS. manufactured by OHM PHARMA INC. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20211229.

Generic name
AVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, NUX VOMICA, PASSIFLORA, INCARNATA, STRAMONIUM, VALERIANA OFFICINALIS.
Manufacturer
OHM PHARMA INC.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
66096-727
Application
N/A
Label effective
20211229

Active ingredients

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.

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.

Contraindications

Not available.

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.

Adverse Reactions

Not available.