INSOMNIA- aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis liquid
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:

Aquilegia Vulgaris 2X, Avena Sativa 2X, Chamomilla 2X, Coffea Cruda 6X, Cypripedium Pubescens 3X, Humulus Lupulus 3X, Hypericum Perforatum 6X, Kali Phosphoricum 12X, Melatonin 6X, Melissa Officinalis 3X, Natrum Muriaticum 30C, Passiflora Incarnata 2X, Valeriana Officinalis 2X.

INDICATIONS:

Relaxing homeopathic oral spray for the temporary relief anxiety & restlessness associated with occasional sleeplessness.†

†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 prior to bedtime and when sleep is interrupted by restlessness. Children 12 & under. Consult a doctor prior to use.

INDICATIONS:

Relaxing homeopathic oral spray for the temporary relief anxiety & restlessness associated with occasional sleeplessness.†

†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# 69607-0002-1

BIOVEA

HOMEOPATHICS

Insomnia

Homeopathic

1 FL. OZ. (30ml)

RELAXATION & SLEEP†

Insomnia

INSOMNIA
aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69607-0002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AQUILEGIA VULGARIS (UNII: 8POZ61U1G2) (AQUILEGIA VULGARIS - UNII:8POZ61U1G2)	AQUILEGIA VULGARIS	2 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	2 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X] in 1 mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	3 [hp_X] in 1 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	3 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X] in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	12 [hp_X] in 1 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	6 [hp_X] in 1 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	3 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_C] 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
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	2 [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:69607-0002-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/11/2017	03/23/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/02/2015	03/23/2022

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(69607-0002) , api manufacture(69607-0002) , label(69607-0002) , pack(69607-0002)

Revised: 1/2022

Document Id: 40db71e3-7631-4190-9a51-e00eec9960a7

Set id: 92a312cc-ef36-4f6b-9f9f-e81045f28934

Version: 5

Effective Time: 20220124

Biovea