Label: RESPOSOOTHE- aconitum napellus, arsenicum album, bryonia, cuprum metallicum, phosphorus 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 October 18, 2016

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

  • HPUS Active Ingredients:

    Equal volumes of each ingredient: Aconitum napellus 30C, Arsenicum album 30C, Bryonia 30C, Cuprum metallicum 30C, Phosphorus 6C.

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  • Uses*:

    For temporary relief of tight chest, wheezing, & chest congestion associated with colds & seasonal allergies.

    *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 3 times daily. Use additionally as needed or until symptoms improve. Adults: Take 3 pump sprays. Children under 12: Take 2 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 mroe 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

    Temporarily relieves tight chest, wheezing, & chest congestion associated with colds & seasonal allergies

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  • INGREDIENTS AND APPEARANCE
    RESPOSOOTHE 
    aconitum napellus, arsenicum album, bryonia, cuprum metallicum, phosphorus spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-262
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_C]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+) 30 [hp_C]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_C]  in 59 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 30 [hp_C]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 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:68703-262-02 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/24/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/24/2016
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio 617901350 api manufacture(68703-262) , manufacture(68703-262)
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