decongestant/narcotic antitussive/acetaminoph/antihistamine - oral (cont.)
PRECAUTIONS: See also Warning section.Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; 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, gallbladder disease, pancreatitis), adrenal gland problem (e.g., Addison's disease), certain brain disorders (e.g., head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema, sleep apnea), diabetes, a certain eye problem (glaucoma), heart problems, high blood pressure, kidney problems, liver disease, mental/mood problems (e.g., depression, psychosis), seizures, stomach/intestinal problems (e.g., ulcers, blockage), thyroid problems (e.g., hyperthyroidism, hypothyroidism), urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention), use/abuse of drugs/alcohol.This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcohol.To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Children may be more sensitive to the side effects of antihistamines. In young children, antihistamines may cause agitation/excitement instead of drowsiness. Children may also be more sensitive to the side effects of the narcotic cough suppressant, especially extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, confusion, constipation, trouble urinating, fast/irregular heartbeat, trouble sleeping, or slow/shallow breathing. Dizziness, drowsiness, trouble sleeping, and confusion can increase the risk of falling.During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell your doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.This product may pass into breast milk. Consult your doctor before breastfeeding. Products that contain codeine or dihydrocodeine 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. If your product contains codeine or dihydrocodeine, discuss the risks and benefits with your doctor before breast-feeding.
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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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