NativeRemedies® SlumberPax™

SlumberPax by

Drug Labeling and Warnings

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

Drug Details [pdf]

SLUMBERPAX- cinchona, coffea cruda, kali phos, nux vom, staphysag 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® SlumberPax™

HPUS Active Ingredients

Each dose contains equal parts of: Cinchona (30C), Coffea cruda (30C), Kali phos (6C), Nux vom (30C), Staphysag (30C).

Uses

Soothes night time physical & mental restlessness and the inability to 'wind down'.

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

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use one hour before bedtime and again if you wake up during the night. Adults & 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.

Citric acid, potassium sorbate, purified water.

Keep this and all medication out of reach of children.

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

Assists with intermittent stress-related night time restlessness

SLUMBERPAX 
cinchona, coffea cruda, kali phos, nux vom, staphysag spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-260
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	30 [hp_C]  in 59 mL
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q)	COFFEA ARABICA FRUIT	30 [hp_C]  in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	6 [hp_C]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C]  in 59 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	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: 68703-260-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/12/2016	02/11/2020

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	manufacture(68703-260) , api manufacture(68703-260)

Revised: 2/2020

Document Id: 9e523b15-9a26-79e0-e053-2995a90ac226

34390-5

Set id: 353c989f-2c04-6a51-e054-00144ff88e88

Version: 2

Effective Time: 20200211

 

Silver Star Brands