Antihistamine, decongestant, and analgesic combination Oral

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long time.

Get emergency help immediately if any of the following symptoms of overdose occur:

• Clumsiness or unsteadiness
• convulsions (seizures)
• drowsiness (severe)
• dryness of mouth, nose, or throat (severe)
• fast heartbeat
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• headache (continuing and/or severe)
• increased sweating
• nausea or vomiting (severe or continuing)
• shortness of breath or troubled breathing
• stomach cramps or pain (severe or continuing)
• trouble in sleeping

Signs of severe acetaminophen overdose may not appear until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

• Diarrhea
• loss of appetite
• swelling or tenderness in the upper abdomen or stomach area

• Any loss of hearing
• bloody urine
• changes in behavior (in children)
• confusion
• diarrhea (severe or continuing)
• drowsiness or tiredness (severe, especially in children)
• fast or deep breathing (especially in children)
• fever
• ringing or buzzing in ears (continuing)
• uncontrollable flapping movements of the hands (especially in elderly patients)
• unusual thirst
• vision problems

Check with your doctor as soon as possible if any of the following side effects occur:

• Nausea or vomiting
• stomach pain (mild)

• Bloody or black tarry stools
• changes in urine or problems with urination
• skin rash, hives, or itching
• sore throat and fever
• swelling of face, feet, or lower legs
• tightness in chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weight gain (unusual)
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Drowsiness
• heartburn or indigestion (for salicylate-containing medicines)
• thickening of mucus

• Blurred vision
• confusion
• difficult or painful urination
• dizziness
• dryness of mouth, nose, or throat
• headache
• loss of appetite
• nightmares
• pounding heartbeat
• ringing or buzzing in ears
• skin rash
• stomach upset or stomach pain
• unusual excitement, nervousness, restlessness, or irritability

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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