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

Combination Remedy 20 - Insomnia by

Drug Labeling and Warnings

Combination Remedy 20 - Insomnia by is a Homeopathic medication manufactured, distributed, or labeled by Warsan Homoeopathic Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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

Keep out of reach of children.

ACTIVE INGREDIENT

Coffea Cruda 1X

Hyoscyamus Niger 1X

Ignatia Amara 1X

Passiflora Incarnata 1X

Valeriana Officinalis 1x

PURPOSE

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

INACTIVE INGREDIENT

Purified Water

Alcohol

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69008-4070
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	1 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	1 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	1 [hp_X]  in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	1 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	1 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69008-4070-1	20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/15/2017

Labeler - Warsan Homoeopathic Laboratories (645579772)

Registrant - Warsan Homoeopathic Laboratories (645579772)

Establishment
Name	Address	ID/FEI	Business Operations
Warsan Homoeopathic Laboratories		645579772	manufacture(69008-4070) , pack(69008-4070) , label(69008-4070)