Anxiety: Homeopathic Product Information

ANXIETY- chaste tree, avena sativa flowering top, cinchona officinalis bark, hops, hyoscyamus niger, strychnos ignatii seed, passiflora incarnata flowering top and valerian 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 INGREDIENTS:

Agnus Castus 6X, Avena Sativa 1X, Cinchona Officinalis 6X, Humulus Lupulus 2X, Hyoscyamus Niger 200C, Ignatia Amara 200C, Passiflora Incarnata 3X, Valeriana Officinalis 3X.

INDICATIONS:

Calming homeopathic oral spray for the temporary relief of nervousness & sleeplessness associated with anxiety & tension.†

†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 & children over 12. Spray twice under the tongue 3 times per day. For acute symptoms, dosage may be administered up to six times per day. Children 12 & under. Consult a doctor prior to use.

INDICATIONS:

Calming homeopathic oral spray for the temporary relief of nervousness & sleeplessness associated with anxiety & tension.†

†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# 69607-0006-1

BIOVEA

HOMEOPATHICS

Anxiety

Homeopathic

1 FL. OZ. (30ml)

STRESS & SLEEP†

Anxiety
(click image for full-size original)

ANXIETY
agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69607-0006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHASTE TREE (CHASTE TREE) CHASTE TREE 6 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP 1 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 6 [hp_X] in 1 mL
HOPS (HOPS) HOPS 2 [hp_X] in 1 mL
HYOSCYAMUS NIGER (HYOSCYAMUS NIGER) HYOSCYAMUS NIGER 200 [hp_C] in 1 mL
STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 200 [hp_C] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 1 mL
VALERIAN (VALERIAN) VALERIAN 3 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69607-0006-1 30 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2015
Labeler — Biovea (089173699)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (69607-0006), api manufacture (69607-0006), label (69607-0006), pack (69607-0006)

Revised: 07/2015 Biovea

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