GUNA-MELATONIN  - melatonin solution/ drops 
Guna spa

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DRUG FACTS

ACTIVE INGREDIENT

MELATONIN     6X

PURPOSE

Sleep Cycle Support

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of reach of children

INDICATIONS & USAGE

Sleep Cycle Support

WARNINGS

Stop use and ask doctor if symptoms worsen or persist more than 5 days

DIRECTIONS

Take 15 minutes before meals.
Adults and children 12 years and older    20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.
Children  between 12 years and 6 years of age    10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.
Children under 6 years     Ask a doctor.

INACTIVE INGREDIENT

Ethyl Alcohol 30%

PRINCIPAL DISPLAY PANEL

GUNA-MELATONIN  melatonin   solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 17089-397 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELATONIN (MELATONIN) MELATONIN 6 [hp_X]  in 30 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL 9 mL  in 30 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-397-18 1 BOTTLE In 1 BOX contains a BOTTLE, DROPPER 1 30 mL In 1 BOTTLE, DROPPER This package is contained within the BOX (17089-397-18)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/31/2011	04/28/2011

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 04/2011Guna spa