MENSTRUAL CRAMPS AND IRREGULARITIES- cactus grandiflorus, caulophyllum thalictroides, chamomilla, cimicifuga racemosa, colocynthis, ipecacuanha, magnesia phosphorica, sepia, viburnum opulus, xanthoxylum fraxineum 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 grandiflorus, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Colocynthis, Ipecacuanha, Magnesia phosphorica, Sepia, Viburnum opulus, Xanthoxylum fraxineum​. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS

Warnings

• Stop use and ask your doctor if symptoms persist or worsen.
• If pregnant or breast-feeding, take only on advice of a healthcare professional.

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.
• Adults 12 and up: 3 sprays 3 times per day
• Use additionally as needed up to 6 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
• heavy or gushing menstruation
• backache
• menstrual headache
• irregular periods
• lack of menstrual flow

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENSTRUAL CRAMPS AND IRREGULARITIES 
cactus grandiflorus, caulophyllum thalictroides, chamomilla, cimicifuga racemosa, colocynthis, ipecacuanha, magnesia phosphorica, sepia, viburnum opulus, xanthoxylum fraxineum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-0004
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-0004-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/19/2015

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-0004)