SLEEPOLOGY- alfalfa, avena sativa, chamomilla, eschscholtzia californica, gelsemium sempervirens, nux moschata, passiflora incarnata, piper methysticum, valeriana officinalis tablet, chewable 
Bershtel Enterprises

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.

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Active ingredients (in each tablet)

Alfalfa 6X HPUS

Avena sativa 6X HPUS

Chamomilla 6X HPUS

Eschscholtzia californica 6X HPUS

Gelsemium sempervirens 12X HPUS

Nux moschata 9X HPUS

Passiflora incarnata 6X HPUS

Piper methysticum 6X HPUS

Valeriana officinalis 6X HPUS

"HPUS" indicates that this ingredient is officially included in the Homoeopathic Pharmacopoeia of the United States.

Purpose

restless sleep

sleeplessness from nervousness and exhaustion

inability to fall asleep

sleeplessness from stress

sleeplessness from pain, irritability and excitability

frequent waking

sleeplessness from worries and restlessness

inability to fall asleep

restless sleep

Uses*

Addresses sleeplessness and/or restless sleep.

*These "Uses" are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Directions

Adults and children 12 yers of age and older. Chew two tablets at bedtime. Do not swallow whole.

Children 3-11 years of age. Chew one tablet at bedtime. Do not swallow whole.

Children under 3 years of age. Ask a doctor before use.

If pregnant or breast-feeding, ask a doctor before use

Keep out of reach of children.

Inactive ingredients

organic carnuaba wax, organic compliant natural flavor, organic dextrose, organic maltodextrin, organic rice bran extract

Store between 15°-30°C (59°-86°F) in a dry place out of direct sunlight.

BOTTLE IS SAFETY SEALED.

DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

Ask a doctor before use in children under 3 years of age.

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

Keep out of reach of children.

Sleepology

SLEEPOLOGY 
alfalfa, avena sativa, chamomilla, eschscholtzia californica, gelsemium sempervirens, nux moschata, passiflora incarnata, piper methysticum, valeriana officinalis tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-0012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG9 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP6 [hp_X]
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) (PIPER METHYSTICUM ROOT - UNII:BOW48C81XP) PIPER METHYSTICUM ROOT6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP6 [hp_X]
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA6 [hp_X]
ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X) ESCHSCHOLZIA CALIFORNICA6 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
RICE BRAN (UNII: R60QEP13IC)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
Colorwhite (off white) Scoreno score
ShapeROUNDSize10mm
FlavorVANILLAImprint Code G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10564-0012-02 in 1 POUCH; Type 0: Not a Combination Product03/21/2016
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/21/2016
Labeler - Bershtel Enterprises (066659129)

Revised: 1/2018
 
Bershtel Enterprises