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

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

Stress  Insomnia

STRESS AND INSOMNIA 
avena sativa, chamomilla , humulus lupulus, passiflora incarnata tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69607-0011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS3 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (DIAMOND CONVEX) Size6mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69607-0011-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/06/201510/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/06/201510/20/2021
Labeler - Biovea (089173699)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(69607-0011) , api manufacture(69607-0011) , label(69607-0011) , pack(69607-0011)

Revised: 1/2021
 
Biovea