Label: TULA TANTRUM TAMER - matricaria recutita and artemisia cina pre-flowering top granule

  • 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

    Reduces restlessness and tantrums in children

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  • ACTIVE INGREDIENT

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

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  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for tantrums in young children

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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 or breastfeeding, ask a health professional

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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: 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

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  • INACTIVE INGREDIENT

    Inactive Ingredients:Citric acid, corn starch, potassium sorbate, 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 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.

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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
    TULA TANTRUM TAMER 
    chamomilla, cina granule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68703-029
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 6 [hp_C]  in 50 mg
    ARTEMISIA CINA PRE-FLOWERING TOP (ARTEMISIA CINA PRE-FLOWERING TOP) ARTEMISIA CINA PRE-FLOWERING TOP 6 [hp_C]  in 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    STARCH, CORN  
    POTASSIUM SORBATE  
    SUCROSE  
    Product Characteristics
    Color white (White lactose granules) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68703-029-20 20000 mg in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/01/2012
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio 617901350 manufacture(68703-029), api manufacture(68703-029)
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