FESTAL PLUS- cellulase ap3 , pancreatin, simethicone tablet

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Cellulase AP3

Pancreatin

Simethicone

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

DOSAGE & ADMINISTRATION

for oral use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FESTAL PLUS 
cellulase ap3 , pancreatin, simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72988-0038
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	PLUS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72988-0038-1	10 in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2024

Labeler - Lydia Co., Ltd. (695735569)

Registrant - Lydia Co., Ltd. (695735569)

Establishment
Name	Address	ID/FEI	Business Operations
Lydia Co., Ltd.		695735569	manufacture(72988-0038)