|Sinutab Extra Strength Caplets
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ANTIHISTAMINES, DECONGESTANTS, AND ANALGESICS (Systemic)
Some commonly used brand names are:
In the U.S.—
Antihistamine, decongestant, and analgesic combinations are taken by mouth to relieve the sneezing, runny nose, sinus and nasal congestion (stuffy nose), fever, headache, and aches and pain of colds, influenza, and hay fever. These combinations do not contain any ingredient to relieve coughs.
Antihistamines are used to relieve or prevent the symptoms of hay fever and other types of allergy. They may also help relieve some symptoms of the common cold, such as sneezing and runny nose. They work by preventing the effects of a substance called histamine, which is produced by the body. Antihistamines contained in these combinations are:
brompheniramine, chlorpheniramine, dexbrompheniramine, diphenhydramine, pheniramine, phenyltoloxamine, pyrilamine, and triprolidine.
Decongestants, such as phenylephrine, and pseudoephedrine, produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.
Analgesics, such as acetaminophen and salicylates (e.g., aspirin, sodium salicylate), are used in these combination medicines to help relieve fever, headache, aches, and pain.
Some of these medicines are available without a prescription. However, your doctor may have special instructions on the proper dose of these medicines for your medical condition. These medicines are available in the following dosage forms:
Before Using This Medicine
If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For antihistamine, decongestant, and analgesic combinations, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to any of the ingredients contained in this medicine. If this medicine contains aspirin or another salicylate , before taking it, check with your doctor if you have ever had any unusual or allergic reaction to any of the following medicines:
Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy—The occasional use of antihistamine, decongestant, and analgesic combinations is not likely to cause problems in the fetus or in the newborn baby. However, when these medicines are used at higher doses and/or for a long time, the chance that problems might occur may increase. For the individual ingredients of these combinations, the following apply:
Breast-feeding—If you are breast-feeding the chance that problems might occur depends on the ingredients of the combination. For the individual ingredients of these combinations, the following apply:
Children—Very young children are usually more sensitive to the effects of this medicine. Increases in blood pressure, nightmares, unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Also, mental changes may be more likely to occur in young children taking these combination medicines.
Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children . If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional.
Do not give aspirin or other salicylates to a child with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing their use with your child"s doctor . This is very important because salicylates may cause a serious illness called Reye"s syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Also, children may be more sensitive to the aspirin or other salicylates contained in some of these medicines, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.
Adolescents—Do not give aspirin or other salicylates to a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing their use with your child"s doctor . This is very important because salicylates may cause a serious illness called Reye"s syndrome in teenagers with fever caused by a virus infection, especially flu or chickenpox.
Older adults—The elderly are usually more sensitive to the effects of this medicine. Confusion, difficult or painful urination, dizziness, drowsiness, feeling faint, or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly.
Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking antihistamine, decongestant, and analgesic combinations it is especially important that your health care professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine, for example, aspirin or other medicine for allergies. Some medicines may change the way this medicine affects your body. Also, the effect of other medicines may be increased or reduced by some of the ingredients in this medicine.
Other medical problems—The presence of other medical problems may affect the use of antihistamine, decongestant, and analgesic combinations. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine
Take this medicine only as directed . Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.
If this medicine irritates your stomach, you may take it with food or a glass of water or milk, to lessen the irritation.
For patients taking the extended-release tablet form of this medicine:
If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it . This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.
Dosing—The dose of these combination medicines will be different for different products. Follow the directions on the box if you are taking this medicine without a prescription. Or, follow your doctor"s orders if this medicine was prescribed . The following information includes only the average doses for these combinations.
The number of capsules or tablets or teaspoonfuls of liquid that you take depends on the strength of the medicine.
There is a large variety of antihistamine, decongestant, and analgesic combination products on the market. Some products are for use in adults only, while others may be used in children. If you have any questions about this, check with your health care professional.
For cold symptoms and sinus pain and congestion:
Missed dose—If you must take this medicine regularly and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage—To store this medicine:
Precautions While Using This Medicine
Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.
Check with your doctor if your symptoms do not improve or become worse, or if you have a high fever.
The antihistamine in this medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are other antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine .
Also, stomach problems may be more likely to occur if you drink alcoholic beverages while taking a medicine that contains aspirin. In addition, drinking large amounts of alcoholic beverages while taking a medicine that contains acetaminophen may cause liver damage.
The antihistamine in this medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .
The decongestant in this medicine may cause some people to become nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime . If you have any questions about this, check with your doctor.
Also, this medicine may add to the CNS stimulant and other effects of diet aids. Do not use medicines for diet or appetite control while taking this medicine unless you have checked with your doctor .
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.
Antihistamines may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Check the label of all over-the-counter (OTC), nonprescription, and prescription medicines you now take . If any contain acetaminophen or aspirin or other salicylates, including diflunisal or bismuth subsalicylate (e.g., Pepto-Bismol), be especially careful. This combination medicine contains acetaminophen and/or a salicylate. Therefore, taking it while taking any other medicine that contains these drugs may lead to overdose. If you have any questions about this, check with your health care professional.
For patients taking aspirin-containing medicine :
For diabetic patients taking salicylate-containing medicine , false urine sugar test results may occur:
Smaller doses or occasional use usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if:
Get emergency help immediately if any of the following symptoms of overdose occur :
For all combinations
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
For acetaminophen-containing only
Diarrhea; loss of appetite; swelling or tenderness in the upper abdomen or stomach area
For salicylate-containing only
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
Also, check with your doctor as soon as possible if any of the following side effects occur:
Nausea or vomiting; stomach pain (mild)
Less common or rare
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
Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:
Drowsiness; heartburn or indigestion (for salicylate-containing medicines); thickening of mucus
Less common—more common with high doses
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 above may also occur in some patients. If you notice any other effects, check with your doctor.
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