HEADACHE TONIC- not applicable liquid

Headache Tonic by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

Carduus Marianus 1X, Pyrethrum Parthenium 1X, Secale Cornutum 6X, Aconitum Napellus 12X, Belladonna 12X, Bryonia (Alba) 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Melilotus Officinalis 12X, Nux Vomica 12X, Sepia 12X, Spigelia Anthelmia 12X

INDICATIONS:

For temporary relief of throbbing headache with muscular soreness of neck and shoulder pain and fullness, especially in the forehead, occiput and temples, and bursting, splitting headache.

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 throbbing headache with muscular soreness of neck and shoulder pain and fullness, especially in the forehead, occiput and temples, and bursting, splitting headache.

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

HEADACHE TONIC

2 FL OZ (60 ml)

INGREDIENTS AND APPEARANCE

HEADACHE TONIC 
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0261
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	1 [hp_X]  in 1 mL
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K) (TANACETUM PARTHENIUM - UNII:6GE7Z0761K)	TANACETUM PARTHENIUM	1 [hp_X]  in 1 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	6 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	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
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
MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX)	MELILOTUS OFFICINALIS TOP	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
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]  in 1 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	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: 43857-0261-1	60 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/12/2014

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0261) , api manufacture(43857-0261) , label(43857-0261) , pack(43857-0261)