Label: IBABA- chamomilla , mag phos, sucrose granule

  • 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 August 2, 2010

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  • PURPOSE

    Relieves colic and cramping in babies

  • INDICATIONS & USAGE

    Indications: Homeopathic remedy for cramping, colic or digestive discomfort in babies.

  • DOSAGE & ADMINISTRATION

    Dosage: Dissolve a small pinch of granules on baby’s tongue. May be repeated at 20 minute intervals for up to 10 doses if necessary.

  • GENERAL PRECAUTIONS

    Caution: If symptoms persist or worsen, a health care professional should be consulted.

  • ACTIVE INGREDIENT

    Ingredients: Each dose contains equal parts of Chamomilla (6C) (HPUS), Mag phos (6C) (HPUS)
  • INACTIVE INGREDIENT

    Sucrose (inactive ingredient).

  • PREGNANCY

    If pregnant or breastfeeding, ask a health professional before use.

  • WARNINGS

    Contains no gluten, artificial flavors, colors or preservatives. Safe for all ages and during pregnancy.

  • INFORMATION FOR PATIENTS

    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

    The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines from the reach of children.

  • INGREDIENTS AND APPEARANCE
    IBABA 
    chamomilla , mag phos, sucrose granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 100 mg
    MAGNESIUM PHOSPHATE (UNII: 453COF7817) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE6 [hp_C]  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554) 20000 mg  in 20000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68647-103-1020000 mg in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/02/2010
    Labeler - Feelgood Health (538418296)
    Establishment
    NameAddressID/FEIBusiness Operations
    W. Last567284153manufacture
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