PRECAUTIONS: Tell your doctor your medical history, especially of: breathing problems, porphyria (a blood disorder), heart problems, pain (chronic or acute), a history of alcohol or substance abuse, any allergies. Do not drink alcoholic beverages; alcohol adds to the drowsiness caused by this drug. Do not drive or engage in activities that require alertness. A preservative (benzyl alcohol) which may be found in this product or in the liquid used to mix this product (diluent) can infrequently cause serious problems (sometimes death), if given in large amounts (more than 100 mg/kg daily) to an infant during the first months of life (neonatal period). The risk is also greater with low birth weight infants. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor immediately should they occur. If possible, a preservative-free product should be used when treating neonates. Elderly persons are usually more sensitive to the effects of this medication. Use cautiously. This medication is not recommended for use during pregnancy. Consult your doctor before using this medication. This medication has been shown to pass into breast milk and cause harm to a nursing infant. Consult your doctor about breast-feeding.
DRUG INTERACTIONS: This medication can interact with many drugs. Before you take it, tell your doctor of any over-the-counter or prescription drugs you are taking, including: anticoagulants ("blood thinners"), corticosteroids (e.g., prednisone), anti- seizure drugs, heart medications, thyroid medications, anti- depressants, narcotic pain medications (e.g., codeine). This medication can cause drowsiness which will be increased if you are also taking: antihistamines, sedatives, sleeping pills, tranquilizers, muscle relaxers. This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include slowed or fast breathing; cold, clammy skin; change in size of pupil; deep sleep; and loss of consciousness.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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