COMBINATION REMEDY 19 - MIGRAINE HEADACHE- gelsemium semp, ignatia amara, iris versicolor, sanguinaria, spigelia solution/ drops

Combination Remedy 19 - Migraine Headache by

Drug Labeling and Warnings

Combination Remedy 19 - Migraine Headache 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

Gelsemium Semp 4X

Ignatia Amara 6X

Iris Versicolor 4X

Sanguinaria 4X

Spigelia 6X

PURPOSE

Temporary relief from throbbing, pounding headache, nausea, vomiting, chills, sensitivity to light, loss of appetite, increased urination.

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 throbbing, pounding headache, nausea, vomiting, chills, sensitivity to light, loss of appetite, increased urination.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COMBINATION REMEDY 19 - MIGRAINE HEADACHE 
gelsemium semp, ignatia amara, iris versicolor, sanguinaria, spigelia solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69008-4019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	4 [hp_X]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	4 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_X]  in 1 mL
SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B)	SPIGELIA MARILANDICA ROOT	6 [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: 69008-4019-1	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(69008-4019) , pack(69008-4019) , label(69008-4019)