Antihistamine, decongestant, and analgesic combination (oral route)

Alka-Seltzer Plus Cold and Sinus, Genapap Sinus, Infants' Tylenol Plus Cold, Mapap Sinus PE, Sinutab Sinus, Sudafed PE Sinus Headache, Allergy Sinus Medication Extra Strength, Children's Tylenol Cold Bubble Gum Flavor, Children's Tylenol Cold Cherry Flavor, Children's Tylenol Cold Fruit Flavor, Colds And Flu With Vitamin C Extra Strength, Colds And Flu With Vitamin C Regular Strength, Counteract Children's Cold Multi-Symptom Plus Cough, Dimetapp Extra Strength Nighttime Cold, Dimetapp Nighttime Cold, Dristan Extra Strength, Extra Strength Tylenol Allergy Sinus Multi-Symptom Relief, Extra Strength Tylenol Sinus with Coolburst - Nighttime

In November 2000, the Food and Drug Administration (FDA) issued a public health warning regarding phenylpropanolamine (PPA) due to the risk of hemorrhagic stroke. The FDA, supported by results of a research program, requested that manufacturers voluntarily discontinue marketing products that contain PPA and that consumers work with their healthcare providers to select alternative products. 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. Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age.Using these medicines in very young children might cause serious or possibly life-threatening side effects . This product is available in the following dosage forms:

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. 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. Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age.Using these medicines in very young children might cause serious or possibly life-threatening side effects . 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 or 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 children and teenagers 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. 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. 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: Regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or newborn baby. Use of salicylates during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery, or in the newborn baby. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery.Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor. 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: 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 any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take. Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco. The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially: