Tamsulosin hydrochloride 0.4 mg

1 INDICATIONS AND USAGE Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1)

Aurobindo Pharma Limited

FDA Reported Adverse Reactions
`[1] fatigue` `[2] nausea` `[3] drug ineffective` `[4] chronic kidney disease` `[5] dyspnoea` `[6] off label use` `[7] pain` `[8] headache` `[9] diarrhoea` `[10] acute kidney injury`

4 years ago

CAPSULE ORANGE D 53

16 HOW SUPPLIED/STORAGE AND HANDLING

TAMSULOSIN HYDROCHLORIDE capsules USP, 0.4 mg are olive green opaque/orange opaque size ‘0’ hard gelatin capsules imprinted with ‘D’ on cap and ‘53’ on body with black edible ink filled with white to off-white beadlets. Bottles of 100 NDC 65862-598-01 Bottles of 500 NDC 65862-598-05 3 x 10 Unit-dose capsules NDC 65862-598-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in tight container. Avoid excessive moisture. Keep

TAMSULOSIN HYDROCHLORIDE capsules and all medicines out of reach of children.

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