Stix Restart by Winx Health Inc. / Naari Pharma Private Limited

Stix Restart by

Drug Labeling and Warnings

Stix Restart by is a Otc medication manufactured, distributed, or labeled by Winx Health Inc., Naari Pharma Private Limited . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STIX RESTART- levonorgestrel tablet 
Winx Health Inc.

----------

Carton Label

Dose & AdminDose&Admin2

Warning Label

Inactive Ingredients

Usage

No Children

PurposePurpose2

Active Ingredients

STIX RESTART 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80584-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colororange (Light peach) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code 17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80584-102-131 in 1 CARTON01/01/202410/07/2024
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20766009/13/202210/07/2024
Labeler - Winx Health Inc. (117116737)
Establishment
NameAddressID/FEIBusiness Operations
Naari Pharma Private Limited 915787058manufacture(80584-102) , analysis(80584-102) , label(80584-102) , pack(80584-102)

Revised: 10/2024
Document Id: 23fd9500-ad87-91c4-e063-6294a90a50c5
Set id: 0cdf198e-c114-b9fa-e063-6294a90a566a
Version: 5
Effective Time: 20241008
 
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.