COMBINATION REMEDY 16 - MENOPAUSAL COMPLAINTS- cimicifuga racemosa, graphites, sanguinaria canadensis, sepia, sulphur solution/ drops

Combination Remedy 16 - Menopausal Complaints by

Drug Labeling and Warnings

Combination Remedy 16 - Menopausal Complaints 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

Cimicifuga Racemosa 30X

Graphites 30X

Sanguinaria Canadensis 30X

Sepia 30X

Sulphur 30X

PURPOSE

Temporary relief from menopausal complaints, periods that occur less often, headache, irritability, vaginal dryness, hot flashes, low libido.

INACTIVE INGREDIENT

Purified Water

Alcohol

DOSAGE & ADMINISTRATION

Adults 18 years and older: Take 10-15 drops in half cup of water 3 times a day.

Not inteded for use by persons under 18.

INDICATIONS & USAGE

Temporary relief from menopausal complaints, periods that occur less often, headache, irritability, vaginal dryness, hot flashes, low libido.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COMBINATION REMEDY 16 - MENOPAUSAL COMPLAINTS 
cimicifuga racemosa, graphites, sanguinaria canadensis, sepia, sulphur solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69008-4016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X]  in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	30 [hp_X]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	30 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	30 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [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: 69008-4016-1	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	pack(69008-4016) , manufacture(69008-4016) , label(69008-4016)