Combination Remedy 19 – Migraine Headache: Homeopathic Product Information

COMBINATION REMEDY 19 — MIGRAINE HEADACHE- iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, strychnos ignatii seed and spigelia marilandica root 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.

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.

Gelsemium Semp 4X

Ignatia Amara 6X

Iris Versicolor 4X

Sanguinaria 4X

Spigelia 6X

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

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRIS VERSICOLOR ROOT (IRIS VERSICOLOR ROOT) IRIS VERSICOLOR ROOT 4 [hp_X] in 1 mL
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT 4 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X] in 1 mL
STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 6 [hp_X] in 1 mL
SPIGELIA MARILANDICA ROOT (SPIGELIA MARILANDICA ROOT) SPIGELIA MARILANDICA ROOT 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69008-4019-1 20 mL in 1 BOTTLE, DROPPER None
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 Operations
Warsan Homoeopathic Laboratories 645579772 manufacture (69008-4019), pack (69008-4019), label (69008-4019)

Revised: 12/2017 Warsan Homoeopathic Laboratories

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