Label: ORAL SOOTHE- passiflora, chamomilla, calc fluor, calc phos, chamomilla 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 27, 2010

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  • PURPOSE

    Relieves pain, crankiness and crying during teething

  • INDICATIONS & USAGE

    Indications:  Soothing homeopathic remedy for teething in babies and children.

  • DOSAGE & ADMINISTRATION

    Dosage: Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed.

  • GENERAL PRECAUTIONS

    Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children.

  • ACTIVE INGREDIENT

    Ingredients: Each dose contains equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X) (HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)

  • INACTIVE INGREDIENT

    Sucrose (inactive ingredient).

  • WARNINGS

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

  • 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
    ORAL SOOTHE 
    passiflora, chamomilla, calc fluor, calc phos, chamomilla granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]  in 40 mg
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 40 mg
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM FLUORIDE6 [hp_X]  in 40 mg
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) (CALCIUM CATION - UNII:2M83C4R6ZB) ANHYDROUS DIBASIC CALCIUM PHOSPHATE6 [hp_X]  in 40 mg
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_C]  in 40 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554) 20000 mg  in 20000 mg
    Product Characteristics
    Colorwhite (white sucrose granules) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68647-165-1020000 mg in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2010
    Labeler - Feelgood Health (538418296)
    Establishment
    NameAddressID/FEIBusiness Operations
    W. Last567284153manufacture
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