24 HR Metformin hydrochloride 500 MG Extended Release Oral Tablet

1 INDICATIONS & USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Metformin Hydrochloride Extended-release Tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)

Bayshore Pharmaceuticals LLC

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

5 years ago

ROUND WHITE B115

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Table 12:

METFORMIN HYDROCHLORIDE Extended-release Tablets Available Strengths, Units, and Appearance

METFORMIN HYDROCHLORIDE Extended-release Tablets 500 mg Bottles of 100 NDC 76385-128-01 white to off-white color, round, biconvex tablet, having ‘B115’ on one side and plain on the other. Bottles of 500 NDC 76385-128-50 Bottles of 1000 NDC 76385-128-10 750 mg Bottles of 100 NDC 76385-129-01 white to off-white color, capsule shape, biconvex tablet, having 'B116' on one side and plain on the other. Bottles of 500 NDC 76285-129-50 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted within 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in light-resistant container.

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24 HR Metformin hydrochloride 500 MG Extended Release Oral Tablet

FDA Reported Adverse Reactions [1] drug ineffective [2] nausea [3] fatigue [4] off label use [5] diarrhoea [6] dyspnoea [7] pain [8] headache [9] vomiting [10] death

ROUND WHITE B115

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