Label: CROUPEX SPRINKLES- aconitum nap , hepar sulph calc , kali mur , mag phos , rumex crisp , 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 July 22, 2010

If you are a consumer or patient please visit this version.

  • PURPOSE

    Relieves croup and barking cough

  • INDICATIONS & USAGE

    Indications:  Homeopathic remedy for dry, barking cough in children.

  • DOSAGE & ADMINISTRATION

    Dosage: 1 pinch onto the tongue every 20 minutes. Children 1-12 years may use together with Congesto-K KiddieRub™ for combined support.

  • 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 Aconitum nap (30C) (HPUS), Hepar sulph calc (6C) (HPUS), Kali mur (6X) (HPUS), Mag phos (6X) (HPUS), Rumex crisp (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
    CROUPEX SPRINKLES 
    aconitum nap , hepar sulph calc , kali mur , mag phos , rumex crisp , sucrose granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 40 mg
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE6 [hp_C]  in 40 mg
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE6 [hp_X]  in 40 mg
    MAGNESIUM PHOSPHATE (UNII: 453COF7817) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE6 [hp_X]  in 40 mg
    RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN6 [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:68647-106-1020000 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