TENSION HEACACHE- aconitum napellus, carduus marianus, coffea cruda, dioscorea villosa, gelsemium sempervirens, gnaphalium polycephalum, iris versicolor, passiflora incarnata, stellaria media, verbascum thapsus spray

Tension Heacache by

Drug Labeling and Warnings

Tension Heacache by is a Homeopathic medication manufactured, distributed, or labeled by Biovea, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INTREDIENTS:

Aconitum Napellus 200C, Carduus Marianus 3X, Coffea Cruda 200C, Dioscorea Villosa 3X, Gelsemium Sempervirens 3X, Gnaphalium Polycephalum 3X, Iris Versicolor 3X, Passiflora Incarnate 2X, Stellaria Media 3X, Verbascum Thapsus 3X.

INDICATIONS:

Fast-acting homeopathic oral spray for the temporary relief of dull or sharp pain, pressure, or neck and shoulder tension associated with tension headaches.†

†These statements are based upon traditional homeopathic practice.  They have not been reviewed by the Food and Drug Administration.

WARNINGS:

If symptoms persist, consult a doctor.

If pregnant or breast feeding, ask a doctor before use.

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

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

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

Adults and children over 12.  Spray twice under tongue every 30 minutes as needed.

Children 12 and under.  Consult a doctor prior to use.

INDICATIONS:

Fast-acting homeopathic oral spray for the temporary relief of dull or sharp pain, pressure, or neck and shoulder tension associated with tension headaches.†

†These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, purified water.

QUESTIONS:

Distributed by: BIOVEA

Dallas, TX 75202

1-800-961-4750

www.biovea.com

PACKAGE LABEL DISPLAY:

NDC# 69607-0004-1

BIOVEA

HOMEOPATHICS

Tension Headache

Homeopathic

1 FL. OZ. (30ml)

NATURAL RELIEF

INGREDIENTS AND APPEARANCE

TENSION HEACACHE 
aconitum napellus, carduus marianus, coffea cruda, dioscorea villosa, gelsemium sempervirens, gnaphalium polycephalum, iris versicolor, passiflora incarnata, stellaria media, verbascum thapsus spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69607-0004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	200 [hp_C]  in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	3 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	200 [hp_C]  in 1 mL
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA TUBER	3 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	3 [hp_X]  in 1 mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	3 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	3 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]  in 1 mL
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	3 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	3 [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: 69607-0004-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/07/2015

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(69607-0004) , api manufacture(69607-0004) , label(69607-0004) , pack(69607-0004)