BIO HEATHER- calluna vulgaris, flos 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.

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Drug Facts:

ACTIVE INGREDIENTS:

Calluna Vulgaris 6X, 30C, 200C.

INDICATIONS:

For temporary relief of being overly talkative, needing to speak about personal matters or seek out companionship indiscriminately.


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 a 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 being overly talkative, needing to speak about personal matters or seek out companionship indiscriminately.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

BIO HEATHER

6X, 30C, 200C

HOMEOPATHIC

1 FL OZ (30 ml)

Bio Heather

BIO HEATHER 
calluna vulgaris, flos liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0491
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV) (CALLUNA VULGARIS FLOWERING TOP - UNII:D9PC510CQV) CALLUNA VULGARIS FLOWERING TOP6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0491-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/20/2018
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0491) , api manufacture(43857-0491) , label(43857-0491) , pack(43857-0491)

Revised: 8/2018
Document Id: 6b0d449c-6c34-4842-b4b1-997f7bf1e804
Set id: 69763de6-b161-450d-a2ca-25953168ccb7
Version: 1
Effective Time: 20180820
 
BioActive Nutritional, Inc.