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

FESTAL PLUS by

Drug Labeling and Warnings

FESTAL PLUS by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ursodeoxycholic Acid, Pancreatin, Simethione

PURPOSE

digestion

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

WARNINGS

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

For oral use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FESTAL PLUS 
ursodeoxycholic acid, simethicone, pancreatin, cellulase ap3 tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR)	URSODIOL	10 mg
PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O)	PANCRELIPASE LIPASE	315 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	30 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0010-1	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/21/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/21/2018

Labeler - OASIS TRADING (689991468)

Registrant - OASIS TRADING (689991468)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS TRADING		689991468	manufacture(72689-0010)