Atropine Sulfate 0.025 MG Diphenoxylate Hydrochloride 2.5 MG Oral Tablet

INDICATIONS AND USAGE Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea.

Aphena Pharma Solutions - Tennessee, LLC

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

2 years ago

ROUND WHITE M 15

HOW SUPPLIED Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP are available containing 2.5 mg of diphenoxylate hydrochloride, USP (Warning: May be habit forming) and 0.025 mg of atropine sulfate, USP. The tablets are white round, unscored tablets debossed with M over 15 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0415-77 bottles of 90 tablets NDC 0378-0415-01 bottles of 100 tablets NDC 0378-0415-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Pharmacist: Dispense with a child-resistant closure only. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED NOVEMBER 2009 DPXAS:R12

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