Label: MOODCALM- hyoscyamus, kali phos, nat sulphuricum, tarentula hisp, acacia gum, lactose, magnesium stearate, corn starch, sucrose tablet

  • 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 July 16, 2015

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  • PURPOSE

    Calms emotional outbursts and agitation and reduces mood swings

  • ACTIVE INGREDIENT

    Active Ingredients:Each dose contains equal parts of: Hyoscyamus 6C HPUS, Kali phos 6X HPUS, Nat sulphuricum 6X HPUS, Tarentula hisp 6C HPUS

  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for acute agitation, restlessness or over excitement

  • WARNINGS

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant of 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: Take 2 tablets every 30 minutes. Serving may be repeated as needed for up to 10 servings. Alternatively, for small babies, crush tablets and sprinkle onto tongue. Special instructions: Avoid strong mint-flavored candy

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acacia gum, lactose, magnesium stearate, corn 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.
    Siute 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
    MOODCALM 
    hyoscyamus, kali phos, nat sulphuricum, tarentula hisp, acacia gum, lactose, magnesium stearate, corn starch, sucrose tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER6 [hp_C]
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE6 [hp_X]
    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:68703-018-80180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2012
    Labeler - Silver Star Brands, Inc (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-018) , api manufacture(68703-018)
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