Label: TREMORSOOTHE - amanita muscaria var. muscaria fruiting body, magnesium phosphate, dibasic trihydrate, datura stramonium and lycosa tarantula tablet

  • 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 01/13

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

  • PURPOSE

    Controls shakes, tremors, twitches and muscle spasms

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  • 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)

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  • INDICATIONS & USAGE

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

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  • WARNINGS

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

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  • PREGNANCY OR BREAST FEEDING

    If pregnant of breastfeeding, ask health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children

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  • OVERDOSAGE

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

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  • 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.

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  • INACTIVE INGREDIENT

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

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  • 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.

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  • STORAGE AND HANDLING

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

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  • INGREDIENTS AND APPEARANCE
    TREMORSOOTHE  
    agaricus musc, mag phos, stramonium, tarentula hisp tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68703-008
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY (AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY) AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY 6 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X]
    DATURA STRAMONIUM (DATURA STRAMONIUM) DATURA STRAMONIUM 6 [hp_C]
    LYCOSA TARANTULA (LYCOSA TARANTULA) LYCOSA TARANTULA 6 [hp_C]
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    LACTOSE  
    MAGNESIUM STEARATE  
    STARCH, CORN  
    SUCROSE  
    Product Characteristics
    Color white (White lactose tablets) Score no score
    Shape ROUND (Round white lactose tablets) Size 6mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68703-008-80 180 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/30/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio 617901350 manufacture(68703-008), api manufacture(68703-008)
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