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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

(in each tablet) Avena Sativa 6X, Chamomilla 4X, Coffea Cruda 4X, Nux Vomica 6X, Passiflora Incarnata 6X.

PURPOSE:

Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.

USES:

Nighttime sleep aid

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.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

• Adults and children 12 years and above, dissolve 1 to 3 tablets under tongue 1/2 to 1 hour before bedtime.

• Children under 12 years, consult a physician.

OTHER INFORMATION:

Store tightly closed in a dry place

• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

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

States

• These statements are supported by the traditional homeopathic principles

Lactose, Magnesium Stearate, Microcrystaline Cellulose.

QUESTIONS:

Dist. by:

The Magni Group, Inc.

McKinney, TX 75071 USA

www.magnilife.com

1-800-645-9199

PACKAGE LABEL DISPLAY:

MAGNILIFE®         HOMEOPATHIC 

SLEEP ASSIST       NDC 43689-0018-1

For sleeplessness and

difficulty falling asleep

125 Tablets

SLEEP ASSIST LBL

SLEEP ASSIST CTN

SLEEP ASSIST 
chamomilla, coffea cruda, avena sativa, nux vomica, passiflora incarnata tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0018
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE4 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN4 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP6 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Convex) Size6mm
FlavorImprint Code ML
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43689-0018-21 in 1 CARTON06/19/2023
1NDC:43689-0018-1125 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/19/2023
Labeler - The Magni Company (113501902)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43689-0018) , api manufacture(43689-0018) , label(43689-0018) , pack(43689-0018)

Revised: 6/2023
Document Id: a34ebc40-4dfa-4cbf-8937-c8732954ea09
Set id: a7e428d3-9460-48d0-9c8d-1e8846bec857
Version: 1
Effective Time: 20230619
 
The Magni Company