Label: TREMORSOOTHE- agaricus musc, mag phos, stramonium, tarentula hisp tablet

  • 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 July 16, 2015

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  • PURPOSE

    Controls shakes, tremors, twitches and muscle spasms

  • ACTIVE INGREDIENT

    Active Ingredients: Each tablet contains equal parts of: Agaricus musc(6C) (HPUS), Mag phos (8X) (HPUS), Stramonium (6C) (HPUS), Tarentula hisp (6C) (HPUS)

  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for tremors, shakes and spontaneous nerve spasms.

  • WARNINGS

    Warnings:If symptoms persist or worsen, consult a healthcare professional.

  • PREGNANCY OR BREAST FEEDING

    If pregnant of breastfeeding, ask 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: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. For all ages: Take 2 tablets 3 times daily until symptoms subside. Special instruction: Dosage may be repeat every 30 minutes if needed during acute episodes.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acacia gum, lactose, magnesium stearate, starch, sucrose

  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United 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.
    Suite 160
    Boca Raton, Fl 33487
    Phone:+1.877.289.1235
    International:+1.561.999.8857

    Contains no artificial flavors or artificial colors. No gluten added.

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    Bottle label

  • INGREDIENTS AND APPEARANCE
    TREMORSOOTHE 
    agaricus musc, mag phos, stramonium, tarentula hisp tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY6 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM6 [hp_C]
    LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT) LYCOSA TARANTULA6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (White lactose tablets) Scoreno score
    ShapeROUND (Round white lactose tablets) Size6mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-008-80180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/30/2013
    Labeler - Silver Star Brands, Inc (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-008) , api manufacture(68703-008)
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