NativeRemedies® QuitCalm™ Oral Spray

QuitCalm by

Drug Labeling and Warnings

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

Drug Details [pdf]

QUITCALM- arsenicum iodatum, bromium, chamomilla, nux vomica, staphysagria 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® QuitCalm™ Oral Spray

HPUS Active Ingredients:

Equal volumes of each ingredient: Arsenicum iodatum 30C, Bromium 6C, Chamomilla 30C, Nux vomica 6C, Staphysagria 30C.

Uses*:

Assists with occasional moodiness and agitation associated with nicotine withdrawal. Nicotine free.

*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 up to 10 times daily for the first 10 days and as needed thereafter. Adults: Take 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.

Assists with occasional moodiness & agitation associated with nicotine withdrawal

QUITCALM 
arsenicum iodatum, bromium, chamomilla, nux vomica, staphysagria spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-274
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_C]  in 59 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_C]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	30 [hp_C]  in 59 mL
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIIODIDE	30 [hp_C]  in 59 mL
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G)	BROMINE	6 [hp_C]  in 59 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-274-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/19/2016	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(68703-274) , manufacture(68703-274)

Revised: 2/2020

Document Id: 9e5211ea-6929-6506-e053-2995a90a7af8

34390-5

Set id: 439023f1-5a85-3160-e054-00144ff88e88

Version: 2

Effective Time: 20200211

 

Silver Star Brands