MEDI-DOZE RX SLEEP AID- melatonin, .gamma.-aminobutyric acid and valerian tablet 
Two Hip Consulting, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

SLEEP AID

*DO NOT TAKE THIS PRODUCT IF YOU ARE DRIVING OR USING MACHINERY

WARNING:

CONSULT YOUR PHYSICIAN BEFORE USING THIS PRODUCT IF YOU ARE PREGNANT, LACTATING, OR ARE BEING TREATED FOR A SERIOUS MEDICAL CONDITION. KEEP OUT OF REACH OF CHILDREN.

STORE IN A COOL, DRY PLACE. IF SEAL IS BROKEN, DO NOT USE.

MEDI-DOZE

SLEEP AID

MELATONIN, GABA, VALERIAN

AMOUNT PER SERVING

MELATONIN 6 MG

GAMMA AMINOBUTYRIC ACID 30 MG

VALERIAN 50 MG

ONE TABLET 1 TO 2 HOURS BEFORE BEDTIME (SUGGESTED).

Medi-Sulting-Medi-Doze_Label-Final

MEDI-DOZE RX  SLEEP AID
melatonin .gamma.-aminobutyric acid valerian tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76074-451
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN6 mg
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) (.GAMMA.-AMINOBUTYRIC ACID - UNII:2ACZ6IPC6I) .GAMMA.-AMINOBUTYRIC ACID30 mg
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN50 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76074-451-3130 in 1 BOTTLE; Type 0: Not a Combination Product02/20/201304/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/20/201304/11/2016
Labeler - Two Hip Consulting, LLC (965352896)
Registrant - Two Hip Consulting, LLC (965352896)

Revised: 4/2016
Document Id: 250e5dec-62f3-47eb-8c5a-d71956890c0c
Set id: b450210c-516d-4068-b792-8bed31b26e32
Version: 3
Effective Time: 20160411
 
Two Hip Consulting, LLC