STRESS AND INSOMNIA- avena sativa, chamomilla , humulus lupulus, passiflora incarnata tablet

Stress and Insomnia by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

Avena Sativa 3X, Chamomilla 3X, Humulus Lupulus 3X, Passiflora Incarnata 3X.

INDICATIONS:

Temporary symptomatic relief of simple nervous tension and insomnia (sleeplessness).†

Fall asleep faster and stay asleep†

Relieves stress to help you rest†

Gentle, natural formula†

Your body needs its rest to function properly. Stress & Insomnia Homeopathic Remedy helps you get the good night’s sleep you need, so you can wake up refreshed. Our gentle, calming formula uses homeopathic components to relieve the stress and nervousness that can cause insomnia, helping you fall asleep faster and reducing nighttime awakenings. Stress & Insomnia Homeopathic Remedy is the natural way to get the rest you need to feel your best throughout the day. †

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

WARNINGS:

Stop use and ask a doctor if symptoms persist.

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: As a Relaxant: 1 to 2 tablets with water as needed three times daily.

For Occasional Sleeplessness: 1 to 3 tablets 1/2 to 1 hour before retiring.

Children 6-12 years: 1/2 adult dose.

INDICATIONS:

Temporary symptomatic relief of simple nervous tension and insomnia (sleeplessness).†

Fall asleep faster and stay asleep†

Relieves stress to help you rest†

Gentle, natural formula†

Your body needs its rest to function properly. Stress & Insomnia Homeopathic Remedy helps you get the good night’s sleep you need, so you can wake up refreshed. Our gentle, calming formula uses homeopathic components to relieve the stress and nervousness that can cause insomnia, helping you fall asleep faster and reducing nighttime awakenings. Stress & Insomnia Homeopathic Remedy is the natural way to get the rest you need to feel your best throughout the day. †

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

INACTIVE INGREDIENTS:

Lactose, Magnesium Stearate, Microcrystalline Cellulose.

QUESTIONS:

Distributed by: BIOVEA

Dallas, TX 75202

1-800-961-4750

www.biovea.com

PACKAGE LABEL DISPLAY:

NDC# 69607-0011-1

BIOVEA

HOMEOPATHICS

Stress & Insomnia

Homeopathic

100 TABLETS

RELAXATION & STRESS†

INGREDIENTS AND APPEARANCE

STRESS AND INSOMNIA 
avena sativa, chamomilla , humulus lupulus, passiflora incarnata tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69607-0011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	3 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (DIAMOND CONVEX)	Size	6mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69607-0011-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/06/2015

Labeler - Biovea (089173699)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(69607-0011) , api manufacture(69607-0011) , label(69607-0011) , pack(69607-0011)