ANXIETY- agnus castus, avena sativa, cinchona officinalis, humulus lupulus, hyoscyamus niger, ignatia amara, passiflora incarnata, valeriana officinalis 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.

----------

DRUG FACTS:

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A)	CHASTE TREE	6 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	1 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	6 [hp_X] in 1 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	2 [hp_X] in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	200 [hp_C] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	200 [hp_C] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69607-0006-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2015	09/27/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2015	09/27/2022

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(69607-0006) , api manufacture(69607-0006) , label(69607-0006) , pack(69607-0006)

Revised: 3/2022

Document Id: 7bad50aa-d3b5-4b1d-9688-572307af68e3

Set id: 23cafb69-b926-4ae4-8a44-76ffb5e13ce2

Version: 2

Effective Time: 20220309

Biovea