Active Ingredient
Pancreatin 36.46%
Hemicellulase 10.42%
Ox Bile Extract 5.21%
Dimethicone 5.21%
Stozyme
FDA Label NDC 72850-0004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chunwoo Pharmaceutical Co., Ltd. for the product Stozyme (NDC 72850-0004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, keep out of reach of children, warning, uses, indication & usage section, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Food Blue No. 1, Food Yellow No. 4, Colloidal Silicon Dioxide, Microcrystalline Cellulose, Low-Substituted Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose Phthalate, Glyceryl Monostearate, Castor Oil, Hypromellose 2910, Titanium Oxide, Polyethylene Glycol 6000,
Purpose
Anorexia, overeating, and abdominal distention
Keep Out Of Reach Of Children
Keep out of reach of children.
Warning
Do not take if
-you have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medicine contains lactose (sugar) carbohydrates.
-you are under 5
Ask doctor before taking if
- you are on other medication
- you are hypersensitive or have history of allergic response to Tartazine
Keep the proper usage and volume
Stop use and ask a doctor if
- If there is no improvement in the irradiation after 2 weeks of taking the medicine
Uses
for oral use only
Indication & Usage Section
Treats anorexia, overeating, and abdominal distention
Package Label.Principal Display Panel
Label (Label)
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