Melatonin Rapid Release Gelcaps 5mg

Melatonin Rapid Release Gelcaps 5 mg by

Drug Labeling and Warnings

Melatonin Rapid Release Gelcaps 5 mg by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MELATONIN RAPID RELEASE GELCAPS 5 MG- melatonin rapid release gelcaps capsule 
Granules India Limited

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Melatonin Rapid Release Gelcaps 5mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MELATONIN RAPID RELEASE GELCAPS 5 MG 
melatonin rapid release gelcaps capsule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-796
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	10 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SHELLAC (UNII: MB5IUD6JUA)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
AMMONIA (UNII: 5138Q19F1X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	white (blue grey opaque and yellow opaque hard gelatin capsules)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	G20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-796-38	37500 in 1 BOX	08/16/2017	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/16/2017	07/01/2023

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(62207-796)

Revised: 7/2023

Document Id: 01c20743-9c61-0b0d-e063-6294a90a7cd4

53409-9

Set id: c861b9b5-196f-4439-ab75-247c81055da6

Version: 4

Effective Time: 20230731