promethazine/phenylephrine/codeine - oral (cont.)
PRECAUTIONS: See also Warning section.Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); 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: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), gallbladder disease, adrenal gland problem (e.g., Addison's disease), blood/immune system problems (e.g., bone marrow depression), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema, sleep apnea), diabetes, glaucoma, heart problems (e.g., angina, irregular heartbeat), high blood pressure, liver disease, mental/mood problems (e.g., depression, psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., ulcers, blockage), thyroid disease, trouble urinating (e.g., due to enlarged prostate or urethral stricture), use/abuse of drugs/alcohol.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.)To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)Older adults may be more sensitive to the effects of the drug, especially dizziness, drowsiness, confusion, constipation, trouble urinating, trouble sleeping, fast/irregular heartbeat, or slow/shallow breathing. Dizziness, drowsiness, and confusion can increase the risk of falling.Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.This product passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your infant develops increased sleepiness, trouble breast-feeding, trouble breathing, or unusual limpness. Discuss the risks and benefits with your doctor before breast-feeding.
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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