NativeRemedies® PMS-Away™ Oral Spray

PMS-Away by

Drug Labeling and Warnings

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

Drug Details [pdf]

PMS-AWAY- cacao, calcarea carbonica, cimicifuga racemosa, natrum muriaticum, pulsatilla 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.

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NativeRemedies® PMS-Away™ Oral Spray

HPUS Active Ingredients:

Equal volumes of each ingredient: Cacao 6C, Calcarea carbonica 30Cm Cimicifuga racemosa 6C, Natrum muriaticum 30C, Pulsatilla 6C.

Uses*:

Homeopathic rememdy to temporarily soothe common PMS symptoms of moodiness, bloating, and cramps.

*This statement has not been evaluated by the Food and Drug Adminitration. 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:

Initially, depress pump until pirmed. 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 colornats. 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 common PMS moodiness, bloating & cramps

PMS-AWAY 
cacao, calcarea carbonica, cimicifuga racemosa, natrum muriaticum, pulsatilla spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-295
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	6 [hp_C]  in 59 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]  in 59 mL
COCOA (UNII: D9108TZ9KG) (COCOA - UNII:D9108TZ9KG)	COCOA	6 [hp_C]  in 59 mL
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	30 [hp_C]  in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_C]  in 59 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-295-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/17/2017	02/11/2020

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	api manufacture(68703-295) , manufacture(68703-295)

Revised: 2/2020

Document Id: 9e5278c0-047d-d1e2-e053-2995a90a92b4

34390-5

Set id: 4d11cc46-3937-1561-e054-00144ff8d46c

Version: 2

Effective Time: 20200211

 

Silver Star Brands