Label: COUMARIN- not applicable liquid

  • 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 5, 2014

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

View All Sections
  • ACTIVE INGREDIENTS:

    Coumarinum 6X, 12X, 30X, 12C, 30C

  • INDICATIONS:

    For temporary relief of abdominal bloating, ear congestion, fatigue, gas, headaches, hay fever, generalized itching, and lower back pain.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of abdominal bloating, ear congestion, fatigue, gas, headaches, hay fever, generalized itching, and lower back pain.

  • INACTIVE INGREDIENTS:

    Demineralized water, 25% Ethanol.

  • QUESTIONS:

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

  • PACKAGE LABEL DISPLAY:

    BioActive Homeopathic

    COUMARIN

    1 FL OZ (30 ml)

    Coumarin

  • INGREDIENTS AND APPEARANCE
    COUMARIN 
    not applicable liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0272
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COUMARIN (UNII: A4VZ22K1WT) (COUMARIN - UNII:A4VZ22K1WT) COUMARIN6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0272-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/05/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0272) , api manufacture(43857-0272) , label(43857-0272) , pack(43857-0272)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!