FDA Label for Dimethyl Fumarate

View Indications, Usage & Precautions

Dimethyl Fumarate Product Label

The following document was submitted to the FDA by the labeler of this product Zydus Lifesciences Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel



NDC 70771-1532-3

30-Day Starter Pack Carton Label

Dimethyl Fumarate Delayed-release Capsules

120 mg Starter Dose: 14 Capsules

240 mg Regular Dose: 46 Capsules

Rx only

NDC 70771-1530-7

Dimethyl Fumarate Delayed-release Capsules, 120 mg

14 Capsules

Rx only

NDC 70771-1531-6

Dimethyl Fumarate Delayed-release Capsules, 240 mg

60 Capsules

Rx only


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