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

Menstrual Cramps and Irregularities by

Drug Labeling and Warnings

Menstrual Cramps and Irregularities by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

INDICATIONS & USAGE

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 INGREDIENT

Inactive Ingredients:

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

WARNINGS

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

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

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

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

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