Glucophage XR

[Metformin]

GLUCOPHAGE ® XR (metformin hydrochloride extended-release tablets)
500 mg Bottles of 100 NDC 0087-6063-13
500 mg Bottles of 500 NDC 0087-6063-14
GLUCOPHAGE ® XR 500-mg tablets are white to off-white, capsule shaped, biconvex tablets, with BMS 6063 debossed on one side and 500 debossed across the face of the other side.
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.

Table 12. Most Common Adverse Reactions (> 5.0%) in Placebo-Controlled Studies of GLUCOPHAGE XR*
GLUCOPHAGE XR Placebo n= 781 n= 195
Adverse Reaction % of Patients
Diarrhea 9.6 2.6
Nausea/ Vomiting 6.5 1.5

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Table 11. Most Common Adverse Reactions (> 5.0%) in a Placebo-Controlled Clinical Study of GLUCOPHAGE Monotherapy*
GLUCOPHAGE Monotherapy Placebo n= 141 n= 145
Adverse Reaction % of Patients
Diarrhea 53.2 11.7
Nausea/ Vomiting 25.5 8.3
Flatulence 12.1 5.5
Asthenia 9.2 5.5
Indigestion 7.1 4.1
Abdominal Discomfort 6.4 4.8
Headache 5.7 4.8

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