COMBINATION REMEDY 20 - INSOMNIA- coffea cruda, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis solution/ drops 
Warsan Homoeopathic Laboratories

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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Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

If pregnant or breast-feeding, ask health professional before use.

Do not use if tamper evident seal is missing or broken.

Keep out of reach of children.

Coffea Cruda 1X

Hyoscyamus Niger 1X

Ignatia Amara 1X

Passiflora Incarnata 1X

Valeriana Officinalis 1x

Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.

Purified Water

Alcohol

Adults and children 12 years and older: Take 10-15 drops in half cup of water 3 times a day.

Children 2 years to under 12 years: Take 8-10 drops in half cup of water of 3 times a day.

Children under 2 years: Consult doctor prior to use.

Temporary relief from difficulty sleeping, unrefreshing sleep, daytime drowsiness, nervous exhaustion.

insomnia combo 20 rev.jpg

COMBINATION REMEDY 20 - INSOMNIA 
coffea cruda, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69008-4070
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED1 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN1 [hp_X]  in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER1 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69008-4070-120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/15/2017
Labeler - Warsan Homoeopathic Laboratories (645579772)
Registrant - Warsan Homoeopathic Laboratories (645579772)
Establishment
NameAddressID/FEIBusiness Operations
Warsan Homoeopathic Laboratories645579772manufacture(69008-4070) , pack(69008-4070) , label(69008-4070)

Revised: 12/2017
Document Id: 612d2bd5-63bc-fcbc-e053-2a91aa0a6112
Set id: 5e576e66-1008-25a9-e053-2a91aa0a3d2e
Version: 2
Effective Time: 20171225
 
Warsan Homoeopathic Laboratories