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FDA Approval

Hyoscyamine Sulfate Extended-Release

CompanyAidarex Pharmaceuticals LLC (DUNS: 801503249)

Effective Date

January 5, 2014

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hyoscyamine(0.375 mg in 1 1)

Products (1)

Hyoscyamine Sulfate Extended-Release

NDC Product Code

33261-907

Route of Administration

ORAL

Effective Date

January 5, 2014

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HyoscyamineActive

Code: F2R8V82B84Class: ACTIBQuantity: 0.375 mg in 1 1

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