INSOMNIA RELIEF- passiflora incarnata, valeriana officinalis, avena sativa, cuprum aceticum, hyoscyamus niger liquid 
HOMEOLAB USA INC.

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


Homeopathic Liquid Attenuations

ACTIVE INGREDIENTS HPUS

Passiflora incarnata 2X

Valeriana officinalis 2X

Avena sativa 2X

Cuprum aceticum 9X

Hyoscyamus niger 9X

Alcohol 13 %

Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

PURPOSE

Relieves Restlessness, Nervousness and Anxiety Associated with Insomnia

USES

This is a natural Homeopathic remedy that relieves restlessness, nervousness and anxiety associated with insomnia.

WARNINGS

If symptoms persist or worsen, discontinue use and contact a health professional.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Keep this and all medications out of reach of children.

DIRECTIONS

Adults: 15-20 drops under the tongue or in a teaspoonful of water 3 times a day. Not for use by children.

OTHER INFORMATION

Do not use if cap seal is broken.

Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

PRODUCT OF CANADA

1-800-404-4666

CARTON

IMAGE OF CARTONIMAGE OF LABEL

INSOMNIA RELIEF 
passiflora incarnata, valeriana officinalis, avena sativa, cuprum aceticum, hyoscyamus niger liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-2008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP2 [hp_X]  in 30 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]  in 30 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]  in 30 mL
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION9 [hp_X]  in 30 mL
HYOSCYAMUS NIGER WHOLE (UNII: 34412PDT5E) (HYOSCYAMUS NIGER WHOLE - UNII:34412PDT5E) HYOSCYAMUS NIGER WHOLE9 [hp_X]  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-2008-430 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/11/2013
Labeler - HOMEOLAB USA INC. (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC.202032533manufacture(60512-2008)

Revised: 11/2013
Document Id: 23a1b9b2-e0a0-48b6-ae4e-e42aa659d4ad
Set id: 0e42ef6e-3d76-48e3-b16c-627206f71c56
Version: 2
Effective Time: 20131111
 
HOMEOLAB USA INC.