NativeRemedies® Dysmenorrex™ Oral Spray

Dysmenorrex by

Drug Labeling and Warnings

Dysmenorrex by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DYSMENORREX- chamomilla, magnesia phosphorica, murex purpurea, platinum metallicum, viburnum opulus spray 
Silver Star Brands

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.

----------

NativeRemedies® Dysmenorrex™ Oral Spray

HPUS Active Ingredients:

Equal volumes of each ingredient in a 6C potency: Chamomilla, Magnesia phosphorica, Murex purpurea, Platinum metallicum, Viburnum opulus.

Uses*:

Homeopathic remedy to help soothe and reduce menstrual cramps and period pains.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Initally, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily until symptoms improve. Adults and children 12+: 3 pump sprays.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding, ask a health professional before use.

Soothes menstrual cramps & period pains

DYSMENORREX 
chamomilla, magnesia phosphorica, murex purpurea, platinum metallicum, viburnum opulus spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-297
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805)	VIBURNUM OPULUS BARK	6 [hp_C]  in 59 mL
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY)	PLATINUM	6 [hp_C]  in 59 mL
HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE (UNII: IQV54TN60Y) (HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - UNII:IQV54TN60Y)	HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE	6 [hp_C]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]  in 59 mL
MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC	6 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-297-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/08/2017	01/17/2020

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	manufacture(68703-297) , api manufacture(68703-297)

Revised: 2/2020

Document Id: 9e52b12d-97e8-0cde-e053-2995a90aca98

34390-5

Set id: 4d11a65e-696e-0727-e054-00144ff88e88

Version: 4

Effective Time: 20200211