Menstrual Cramps and Irregularities

MENSTRUAL CRAMPS AND IRREGULARITIES- cactus, caulophyllum, chamomilla, cimicifuga, colocynthis, ipecac, mag phos, sepia, viburnum op, xanthoxylum liquid
King Bio Inc.

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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Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Cactus, Caulophyllum, Chamomilla, Cimicifuga, Colocynthis, Ipecac, Mag phos, Sepia, Viburnum op, Xanthoxylum. Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

Uses for temporary relief of symptoms: cramps, aches and pains, abdominal bloating, irregular periods, menstrual headache, heavy or gushing menstruation, backache, lack of menstrual flow.

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

Warnings

Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children.

Directions

Initially, depress pump until primed.
Spray one dose directly into mouth.
Ages 12 and up: 3 sprays 3 times per day.

Tamper resistant for your protection. Use only if safety seal is intact.

Uses for temporary relief of symptoms:

cramps
aches and pains
abdominal bloating
irregular periods
menstrual headache
heavy or gushing menstruation,
backache
lack of menstrual flow

image description

MENSTRUAL CRAMPS AND IRREGULARITIES
cactus, caulophyllum, chamomilla, cimicifuga, colocynthis, ipecac, mag phos, sepia, viburnum op, xanthoxylum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57955-5004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	10 [hp_X] in 59 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	10 [hp_X] in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X] in 59 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	10 [hp_X] in 59 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	10 [hp_X] in 59 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	10 [hp_X] in 59 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X] in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X] in 59 mL
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805)	VIBURNUM OPULUS BARK	10 [hp_X] in 59 mL
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T)	ZANTHOXYLUM AMERICANUM BARK	10 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARYA OVATA BARK (UNII: X765CF609L)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)
REBAUDIOSIDE A (UNII: B3FUD0528F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57955-5004-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/10/2018

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	manufacture(57955-5004)