metformin hydrochloride 500 mg tablet

1 INDICATIONS & USAGE Metformin Hydrochloride Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin Hydrochloride Tablet is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1)

time cap laboratories, inc

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

3 years ago

ROUND WHITE 134

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 500 mg Bottles of 100 NOC 49483-622-01 500 mg Bottles of 180 NOC 49483-622-81 500 mg Bottles of 500 NOC 49483-622-50 500 mg Bottles of 1000 NOC 49483-622-10 850 mg Bottles of 100 NOC 49483-621-01 850 mg Bottles of 180 NOC 49483-621-81 850 mg Bottles of 500 NDC 49483-621-50 850 mg Bottles of 1000 NOC 49483-621-10 1000 mg Bottles of 100 NDC 49483-620-01 1000 mg Bottles of 180 NDC 49483-620-81 1000 mg Bottles of 500 NDC 49483-620-50 1000 mg Bottles of 1000 NDC 49483-620-10 Metformin Hydrochloride Tablets, USP 500 mg are white to off-white colored, film coated, round shaped tablet with beveled edges on both side and debossed with '134' on one side and plain on other side. Metformin Hydrochloride Tablets, USP 850 mg are white to off-white colored, film coated, round shaped tablet with beveled edges on both side and debossed with '131' on one side and plain on other side. Metformin Hydrochloride Tablets, USP 1000 mg are white to off-white colored, film coated, oval shaped tablet with '132' dabossad on one side and braaklina on both sides. 16.2 Storage Store at 20°-25° C (68°-77° F); excursions permitted to 15°-30° C (59°--86° F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers.

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