Balsalazide disodium 750 MG Oral Capsule

1 INDICATIONS AND USAGE Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use Safety and effectiveness of balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1 ) Limitations of Use: Safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. ( 1 )

apotex corp.

FDA Reported Adverse Reactions
`[1] diarrhoea` `[2] drug ineffective` `[3] injection site pain` `[4] colitis ulcerative` `[5] arthralgia` `[6] nausea` `[7] fatigue` `[8] off label use` `[9] rash` `[10] headache`

4 years ago

CAPSULE WHITE APO B750

16 HOW SUPPLIED/STORAGE AND HANDLING

BALSALAZIDE DISODIUM capsules, USP are available as white, opaque capsules imprinted “APO B750” in red ink.

BALSALAZIDE DISODIUM capsules, USP are supplied as follows: Bottles of 30 (NDC 60505-2575-3) Bottles of 280 (NDC 60505-2575-7) Bottles of 350 (NDC 60505-2575-4) Unit Dose Blister Packs of 10 strips of 10 capsules (NDC 60505-2575-0) Storage Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF). See USP Controlled Room Temperature.

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Balsalazide disodium 750 MG Oral Capsule

FDA Reported Adverse Reactions [1] diarrhoea [2] drug ineffective [3] injection site pain [4] colitis ulcerative [5] arthralgia [6] nausea [7] fatigue [8] off label use [9] rash [10] headache

CAPSULE WHITE APO B750

More pills like CAPSULE APO B750

FDA Reported Adverse Reactions
`[1] diarrhoea` `[2] drug ineffective` `[3] injection site pain` `[4] colitis ulcerative` `[5] arthralgia` `[6] nausea` `[7] fatigue` `[8] off label use` `[9] rash` `[10] headache`