SPL v2
SPL
SPL Set ID 212f5059-da04-595d-e063-6394a90acc64
Route
ORAL
Published
Effective Date 2022-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pancrelipase Lipase (315 mg) Dimethicone (30 mg)
Inactive Ingredients
Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PLUS Shape: oval Color: white Size: 14 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-09-01
Description

Cellulase AP3 Pancreatin Simethicone

Medication Information

Warnings and Precautions

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

Indications and Usage

■ children under 7 years of age: consult a doctor

■ take 1-2 tablet as symptoms accur, as directed by a doctor

Dosage and Administration

for oral use

Description

Cellulase AP3 Pancreatin Simethicone

Section 50565-1

Keep out of reach of children

Section 51727-6

Dextrin, stearic acid, talc, polyethylene glycol 6000

Section 51945-4

Section 55105-1

digestion

Section 55106-9

Cellulase AP3

Pancreatin

Simethicone

Structured Label Content

Indications and Usage (34067-9)

■ children under 7 years of age: consult a doctor

■ take 1-2 tablet as symptoms accur, as directed by a doctor

Dosage and Administration (34068-7)

for oral use

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Dextrin, stearic acid, talc, polyethylene glycol 6000

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

digestion

Section 55106-9 (55106-9)

Cellulase AP3

Pancreatin

Simethicone

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:31.627271 · Updated: 2026-03-14T23:03:38.391930