SLEEP ASSIST- chamomilla, coffea cruda, avena sativa, nux vomica, passiflora incarnata, tablet, orally disintegrating

Sleep Assist by

Drug Labeling and Warnings

Sleep Assist by is a Homeopathic medication manufactured, distributed, or labeled by The Magni Company, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

ACTIVE INGREDIENTS: Chamomilla 4X, Coffea cruda 4X, Avena sativa 6X, Nux vomica 6X, Passiflora incarnata 6X.

Purpose

USES: Temporarily relieves restlessness, sleeplessness, and insomnia, Quiets the nervous system to produce normal sleep.

Warnings

WARNINGS: If pregnant or breastfeeding, ask a health professional before use.

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

Other Information

OTHER SAFETY INFORMATION: Tamper Sealed: Sealed for your protection. Do not use if seal is broken or missing.

Store tightly closed in a cool, dry place (59​​0-86​0F).

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

Dosage

DIRECTIONS:​Adults and children 12 years and above: Dissolve two tablets under tongue in the evening, and two tablets 3-4 hours later, just before bed.

​Children under 12 years: ​Consylt a physician.

Inactive Ingredients

INACTIVE INGREDIENTS: Lactose, Magnesium stearate, Microcrystaline cellulose.

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and usage

USES: Temporarily relieves restlessness, sleeplessness, and insomnia, Quiets the nervous system to produce normal sleep.

Questions

Dist. by:

The Magni Group, Inc.

McKinney, TX 75071 USA

www.magnilife.com

1-800-645-9199

Package label

MAGNILIFE

Homeopathic

NDC: 43689-0002-1

SLEEP ASSIST

For Restlessness, Sleeplessness and Insomnia

125 Tablets

INGREDIENTS AND APPEARANCE

SLEEP ASSIST 
chamomilla, coffea cruda, avena sativa, nux vomica, passiflora incarnata, tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43689-0002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	4 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	4 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	6 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (round convex)	Size	6mm
Flavor		Imprint Code	ML
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43689-0002-1	125 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/10/2012

Labeler - The Magni Company (113501902)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43689-0002)