Headache by BioActive Nutritional, Inc. / Apotheca Company

Headache by

Drug Labeling and Warnings

Headache by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc. , Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEADACHE- melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia, cimicifuga racemosa, gelsemium sempervirens, glonoinum 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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Active Ingredients: Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia, Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis

Indications:For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.

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. 

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

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, get medical help or contact Poison Control Center right away. 

INDICATIONS: For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head. 

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL  32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL  32935  

BioActive Homeopathic

HEADACHE

1 FL OZ (30ml)

HEADACHE 
melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia, cimicifuga racemosa, gelsemium sempervirens, glonoinum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX)	MELILOTUS OFFICINALIS TOP	3 [hp_X]  in 1 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	3 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	12 [hp_X]  in 1 mL
ATROPA BELLADONNA ROOT (UNII: 6MW97Q6E8M) (ATROPA BELLADONNA ROOT - UNII:6MW97Q6E8M)	ATROPA BELLADONNA ROOT	12 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	12 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	12 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]  in 1 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	12 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]  in 1 mL
SANGUINARIA CANADENSIS WHOLE (UNII: B3XJA0OV6T) (SANGUINARIA CANADENSIS WHOLE - UNII:B3XJA0OV6T)	SANGUINARIA CANADENSIS WHOLE	12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
CITHARACANTHUS SPINICRUS (UNII: 3Y5X6RT823) (CITHARACANTHUS SPINICRUS - UNII:3Y5X6RT823)	CITHARACANTHUS SPINICRUS	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0050-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/18/2012	04/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/18/2012	04/21/2020

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0050)

Revised: 9/2018

Document Id: b5b81025-8777-4f58-bc2e-9b87f3a6a34f

34390-5

Set id: 4dbbdcd4-104b-455b-9385-5a5554cc7066

Version: 2

Effective Time: 20180906

 

BioActive Nutritional, Inc.