COUMARIN- not applicable liquid 
BioActive Nutritional, Inc.

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 FACTS

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

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)

Revised: 8/2014
Document Id: 5fe223e3-2c46-401a-a585-0507dd3a5861
Set id: 616f210b-e84a-4119-9ba9-291494ddb80c
Version: 1
Effective Time: 20140805
 
BioActive Nutritional, Inc.