Label: QUITCALM- arsenicum iodatum, bromium, chamomilla, nux vomica, staphysagria spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated December 13, 2016

If you are a consumer or patient please visit this version.

  • HPUS Active Ingredients:

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

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  • 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.

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  • 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.

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  • 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.

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  • OTHER SAFETY INFORMATION

    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.

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  • Inactive Ingredients:

    Citric acid, potassium sorbate, purified water.

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  • KEEP OUT OF REACH OF CHILDREN

    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.

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  • PREGNANCY OR BREAST FEEDING

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

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  • PURPOSE

    Assists with occasional moodiness & agitation associated with nicotine withdrawal

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  • INGREDIENTS AND APPEARANCE
    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
    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)
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