FESTAL PLUS- ursodeoxycholic acid, simethicone, pancreatin, cellulase ap3 tablet 
OASIS TRADING

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.

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Ursodeoxycholic Acid, Pancreatin, Simethione

digestion

Keep out of reach of children

children under 7 years of age: consult a doctor
take 1-2 tablet as symptoms accur, as directed by a doctor

Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
■ Do not take more than 4 tablet in 24 hours
■ Do not use the maximum dosage for more than 2 weeks
Keep out of reach of children

Dextrin, stearic acid, talc, polyethylene glycol 6000, Cellulase AP3

For oral use only

label

FESTAL PLUS 
ursodeoxycholic acid, simethicone, pancreatin, cellulase ap3 tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR) URSODIOL10 mg
PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE315 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0010-110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/21/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0010)

Revised: 11/2018
Document Id: 7b4ab2b8-bdfb-9635-e053-2a91aa0acb4c
Set id: 7b4ab2b8-bdf9-9635-e053-2a91aa0acb4c
Version: 1
Effective Time: 20181122
 
OASIS TRADING