Each MOTRIN® Sinus Headache Caplet contains ibuprofen 200 mg and pseudoephedrine HCl 30 mg.
MOTRIN® Sinus Headache Caplets are indicated for the temporary relief of symptoms associated with sinusitis, the common cold or flu including nasal congestion, headache, body aches, pains and fever.
Do not take more than directed. Adults and children 12 years of age and older: Take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used but do not exceed 6 caplets in 24 hours, unless directed by a doctor. The smallest effective dose should be used. Take with food or milk if occasional and mild heartburn, upset stomach, or stomach pain occurs with use. Consult a doctor if these symptoms are more than mild or if they persist. Children: Do not give this product to children under 12 years of age except under the advice and supervision of a doctor.
Do not take for more than 7 days. If symptoms do not improve, or are accompanied by fever that persists for more than 3 days, or if new symptoms occur, consult a doctor. These could be signs of a serious illness. As with aspirin and acetaminophen, if you have any condition which requires you to take prescription drugs or if you have had any problems or serious side effects from taking any non-prescription pain reliever, do not take this product without first discussing it with your doctor. IF YOU EXPERIENCE ANY SYMPTOMS WHICH ARE UNUSUAL OR SEEM UNRELATED TO THE CONDITION FOR WHICH YOU TOOK THIS PRODUCT CONSULT A DOCTOR BEFORE TAKING ANY MORE OF IT. If you are under a doctor' care for any serious condition, consult a doctor before taking this product. Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, unless directed by a doctor. Do not combine this product with other non-prescription pain relievers. Do not combine this product with any other ibuprofen-containing product. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. IT IS ESPECIALLY IMPORTANT NOT TO USE THIS PRODUCT DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
Allergy Alert: ibuprofen may cause a severe allergic reaction which may include: hives, facial swelling, asthma (wheezing), shock.
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer.
Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away.
Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen may cause stomach bleeding.
Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson' disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your drug contains an MAOI, consult a health professional before taking this product.
The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, also have been reported.
The treatment of acute ibuprofen overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage. Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen. In children, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated. Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation in a health care facility. Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk of convulsions and the potential for aspiration of gastric contents.
In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be admitted to a health care facility for observation.
Symptoms from pseudoephedrine overdose consist most often of mild anxiety, tachycardia and/or hypertension. Symptoms usually appear within 4 to 8 hours of ingestion and are transient, usually requiring no treatment.
Caplets: Carnauba Wax, Cellulose, Corn Starch, FD&C Red #40, Hydroxypropyl Methylcellulose, Silicon Dioxide, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide, Triacetin.
Caplets: (white, printed "Motrin Sinus Headache" in red) in blister packs of 20 and 40.
Store between 20-25°C (68-77°F). Avoid excessive heat.
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