GUNA-MELATONIN- melatonin solution/ drops 
Guna spa

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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DRUG FACTS

ACTIVE INGREDIENT

MELATONIN     4C

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

image of box label

GUNA-MELATONIN 
melatonin solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-458
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN4 [hp_C]  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 9 mL  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17089-458-181 in 1 BOX05/23/201105/23/2011
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/23/201105/23/2011
Labeler - Guna spa (430538264)
Establishment
NameAddressID/FEIBusiness Operations
Guna spa338587646manufacture(17089-458)

Revised: 2/2018
Document Id: 6649f87b-0b33-6738-e053-2a91aa0ae278
Set id: a5a9ba4c-85f0-4c95-b9ba-6e4bebebe657
Version: 2
Effective Time: 20180228
 
Guna spa