Tension Heacache: Homeopathic Product Information

TENSION HEACACHE- aconitum napellus, milk thistle, arabica coffee bean, dioscorea villosa tuber, gelsemium sempervirens root, pseudognaphalium obtusifolium, iris versicolor root, passiflora incarnata flowering top, stellaria media and verbascum thapsus spray
Biovea

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.

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

Tension Headache
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 200 [hp_C] in 1 mL
MILK THISTLE (MILK THISTLE) MILK THISTLE 3 [hp_X] in 1 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 200 [hp_C] in 1 mL
DIOSCOREA VILLOSA TUBER (DIOSCOREA VILLOSA ROOT) DIOSCOREA VILLOSA TUBER 3 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X] in 1 mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 3 [hp_X] in 1 mL
IRIS VERSICOLOR ROOT (IRIS VERSICOLOR ROOT) IRIS VERSICOLOR ROOT 3 [hp_X] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] in 1 mL
STELLARIA MEDIA (STELLARIA MEDIA) STELLARIA MEDIA 3 [hp_X] in 1 mL
VERBASCUM THAPSUS (VERBASCUM THAPSUS) VERBASCUM THAPSUS 3 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69607-0004-1 30 mL in 1 BOTTLE, SPRAY None
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 Operations
Apotheca Company 844330915 manufacture (69607-0004), api manufacture (69607-0004), label (69607-0004), pack (69607-0004)

Revised: 07/2015 Biovea

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