Label: SAD SOOTHER- alumina, aurum met, calc carb, kali phos, nar mur tincture

  • 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 March 25, 2013

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

  • PURPOSE

    Relieves melancholy, loss of libido and sleep problems related to winter blues

  • ACTIVE INGREDIENT

    Active Ingredients: Each dose contains equal parts of: Alumina 30C HPUS, Aurum met 30C HPUS, Calc carb 6C HPUS, Kali phos 6X HPUS, Nat mur 6X HPUS

  • INDICATIONS & USAGE

    Uses:Homeopathic remedy temporarily relieves feelings o sadness related to winter

  • WARNINGS

    Warning:If symptoms persist or worsen, consult a healthcare professional

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions:For all ages: Mix 0.50 mL in 1/4 cup water and sip slowly. Repeat 3-5 times daily as needed until symptoms subside. If preferred, drops may be taken directly into the mouth

  • INACTIVE INGREDIENT

    Inactive Ingredients: USP Purified Water, USP Grain Alcohol 20% by volume

  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the Unites States

    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

    Distributed by
    Native remedies, LLC
    6531 Park of Commerce Blvd.
    Siute 160
    Boca Raton, FL 33487
    Phone: 1.877.289.1235
    International: +1.561.999.8857

    Contains no animal products, gluten, artificial flavors, preservatives or colorants. Suitable for vegetarians

  • STORAGE AND HANDLING

    Tamper resistant for your protection. Use only if safety seal is intact

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    SAD SOOTHER 
    alumina, aurum met, calc carb, kali phos, nar mur tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-092
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE30 [hp_C]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD30 [hp_C]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE6 [hp_C]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-092-5959 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/25/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-092) , api manufacture(68703-092)