Label: RESPOSOOTHE- aconitum napellus, arsenicum album, bryonia, cuprum metallicum, phosphorus spray

  • Category: HUMAN OTC DRUG LABEL

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

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  • HPUS Active Ingredients:

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

  • 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.

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

  • 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.

  • Inactive Ingredients:

    Citric acid, potassium sorbate, purified water.

  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • PURPOSE

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

  • PRINCIPAL DISPLAY PANEL

    RespoSoothe

  • INGREDIENTS AND APPEARANCE
    RESPOSOOTHE 
    aconitum napellus, arsenicum album, bryonia, cuprum metallicum, phosphorus spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-262
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [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) PHOSPHORUS6 [hp_C]  in 59 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER30 [hp_C]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-262-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/24/2016
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350api manufacture(68703-262) , manufacture(68703-262)
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