"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Urex Consumer (continued)
Painful or difficult urination may occur with methenamine, although less often. Report these side effects to your doctor, who may need to lower your dose of methenamine or change your treatment to make your urine less acidic.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Taking higher than recommended doses of methenamine may cause bladder irritation, painful/frequent urination, and bloody/pink urine. Tell your doctor immediately if you have any of these symptoms.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mouth sores, unusual headache, ringing in the ears, muscle cramps, swelling of the arms/legs.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Urex (methenamine hippurate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking methenamine, tell your doctor or pharmacist if you are allergic to it; or to formaldehyde; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, dehydration.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.
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