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Balsalazide Disodium 750 Mg Caps 280 By Roxane Labs.

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Balsalazide Disodium 750 Mg Caps 280 By Roxane Labs.

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Balsalazide Disodium 750 Mg Caps 280 By Roxane Labs. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10050118/RXD4022117/RXA310877
Size : 280
Selling UoM : EA
NDC: 00054-0079-28
UPC Barcode : 300540079284
Supplier: 0050000486 ROXANE LABORATORIES/GENERICS
Supplier Material : 007928
Generic Code : 040304 BALSALAZIDE DISODIUM ORAL CAPSULE 750 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
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Product Description.:

54 795, 54 795
capsule , peach , oblong oblong
OpaqueBlack ink

Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents.

Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.

INDICATIONS AND USAGE

COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established.

CONTRAINDICATIONS

COLAZAL is contraindicated in patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites.

PRECAUTIONS

Of the 259 patients treated with COLAZAL 6.75 grams/day in controlled clinical trials of active disease, exacerbation of the symptoms of colitis, possibly related to drug use, has been reported by 3 patients.

General

Patients with pyloric stenosis may have prolonged gastric retention of COLAZAL capsules.

Drug Interactions

No drug interaction studies have been conducted for COLAZAL, however, the use of orally administered antibiotics could, theoretically, interfere with the release of mesalamine in the colon.