INSOMNIA RELIEF- passiflora incarnata, valeriana officinalis, avena sativa, cuprum aceticum, hyoscyamus niger pellet 
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

ACTIVE INGREDIENTS HPUS

Passiflora incarnata 2X

Valeriana officinalis 2X

Avena sativa 2X

Cuprum aceticum 9X

Hyoscyamus niger 9X

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: Allow 3 or 4 pellets to dissolve in mouth one hour before bedtime. 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

Package Labeling:

NDC 60512-0011-1Inner Label

INSOMNIA RELIEF 
passiflora incarnata, valeriana officinalis, avena sativa, cuprum aceticum, hyoscyamus niger pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0011
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]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION9 [hp_X]
HYOSCYAMUS NIGER WHOLE (UNII: 34412PDT5E) (HYOSCYAMUS NIGER WHOLE - UNII:34412PDT5E) HYOSCYAMUS NIGER WHOLE9 [hp_X]
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-0011-180 in 1 TUBE; Type 0: Not a Combination Product10/18/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/18/2013
Labeler - HOMEOLAB USA INC. (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC.202032533manufacture(60512-0011)

Revised: 1/2020
Document Id: 9cbf852f-1c82-13ea-e053-2995a90a7878
Set id: 1c2531fe-75fe-4dcc-9ea9-d927f70cc4fb
Version: 4
Effective Time: 20200122
 
HOMEOLAB USA INC.