TULA TANTRUM TAMER (CHAMOMILLA, CINA) GRANULE [NATIVE REMEDIES, LLC]

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TULA TANTRUM TAMER (CHAMOMILLA, CINA) GRANULE [NATIVE REMEDIES, LLC]
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NDC 68703-029-20
Set ID 0b217365-aa8e-4fa9-9446-36e1cd265639
Category HUMAN OTC DRUG LABEL
Packager Native Remedies, LLC
Generic Name
Product Class
Product Number
Application Number
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  • PURPOSE

    Reduces restlessness and tantrums in children

  • ACTIVE INGREDIENT

    Active Ingredients: Each dose contains equal parts of: Chamomilla 6C HPUS, Cina 6C HPUS

  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for tantrums in young children

  • WARNINGS

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional

  • 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 5 pilules 2 times daily. Alternatively, for small babies, crush pilules and sprinkle onto tongue. Special instruction: Take on an empty stomach. Avoid strong mint flavored candy

  • INACTIVE INGREDIENT

    Inactive Ingredients:Citric acid, corn starch, potassium sorbate, 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 manufactures 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
    TULA TANTRUM TAMER 
    chamomilla, cina granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 50 mg
    ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP6 [hp_C]  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (White lactose granules) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-029-2020000 mg in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2012
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-029) , api manufacture(68703-029)
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