Label: COUGHEX SPRINKLES- aconitum nap, hepar sulph calc, kali mur, mag phos, rumex crisp 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 November 27, 2012

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

  • PURPOSE

    Temporarily relieves cough

  • ACTIVE INGREDIENT

    Active Ingredients: Each dose contains equal parts of: Aconitum nap 30C HPUS, Hepar sulph calc 6C HPUS, Kali mur 6X HPUS, Mag phos 8X HPUS, Rumex crisp 6C HPUS.

  • INDICATIONS & USAGE

    Uses: Homeopathic temporary relief for dry cough in children.

  • WARNINGS

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

  • PREGNANCY OR BREAST FEEDING

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

  • 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: Children 1-12 years: Sprinkle a pinch onto the tongue every 20 minutes or until symptoms subside.

  • 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 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

    Contain no artificial flavors or artificial colors. No gluten added.

  • STORAGE AND HANDLING

    Tamper resistant seal for your protection. Use only if safety seal is intact.

  • PRINCIPAL DISPLAY PANEL

    Bottle label

  • INGREDIENTS AND APPEARANCE
    COUGHEX SPRINKLES 
    aconitum nap, hepar sulph calc, kali mur, mag phos, rumex crisp granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS30 [hp_C]  in 16 mg
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]  in 16 mg
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE6 [hp_X]  in 16 mg
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 16 mg
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_C]  in 16 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:68703-040-2020000 mg in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/27/2012
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-040) , api manufacture(68703-040)