Label: SAD SOOTHER - aluminum oxide, gold, oyster shell calcium carbonate, crude, potassium phosphate, dibasic and sodium chloride tincture 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

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

  • PURPOSE

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

    Close
  • 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

    Close
  • INDICATIONS & USAGE

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

    Close
  • WARNINGS

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

    Close
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children

    Close
  • OVERDOSAGE

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

    Close
  • 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

    Close
  • INACTIVE INGREDIENT

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

    Close
  • 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

    Close
  • STORAGE AND HANDLING

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

    Close
  • INGREDIENTS AND APPEARANCE
    SAD SOOTHER 
    alumina, aurum met, calc carb, kali phos, nar mur tincture
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68703-092
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM OXIDE (ALUMINUM OXIDE) ALUMINUM OXIDE 30 [hp_C]  in 1 mL
    GOLD (GOLD) GOLD 30 [hp_C]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 6 [hp_C]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) POTASSIUM PHOSPHATE, DIBASIC 6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68703-092-59 59 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 03/25/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio 617901350 manufacture(68703-092), api manufacture(68703-092)
    Close