Antihistamine, decongestant, and analgesic combination (oral route)

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:

• Acetaminophen—Acetaminophen has not been shown to cause birth defects or other problems in humans. However, studies on birth defects have not been done in humans.
• Alcohol—Some of these combination medicines contain large amounts of alcohol. Too much use of alcohol during pregnancy may cause birth defects.
• Antihistamines—Antihistamines have not been shown to cause problems in humans.
• Caffeine—Studies in humans have not shown that caffeine causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount of caffeine contained in 12 to 24 cups of coffee a day).
• Phenylephrine—Studies on birth defects have not been done in either humans or animals with phenylephrine.
• Pseudoephedrine—Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects but did cause a decrease in average weight, length, and rate of bone formation in the animal fetus when administered in high doses.
• Salicylates (e.g., aspirin)—Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin. However, salicylates have been shown to cause birth defects in animals.

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:

• Acetaminophen—Acetaminophen passes into the breast milk. However, it has not been shown to cause problems in nursing babies.
• Alcohol—Alcohol passes into the breast milk. However, the amount of alcohol in recommended doses of this medicine does not usually cause problems in nursing babies.
• Antihistamines—Use is not recommended since the chances are greater for this medicine to cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since antihistamines tend to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some women.
• Caffeine—Small amounts of caffeine pass into the breast milk and may build up in the nursing baby. However, the amount of caffeine in recommended doses of this medicine does not usually cause problems in nursing babies.
• Decongestants (e.g., phenylephrine, pseudoephedrine)—Decongestants may pass into the breast milk and may cause unwanted effects in nursing babies of mothers taking this medicine.
• Salicylates (e.g., aspirin)—Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly.<

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.

• Abrocitinib
• Defibrotide
• Dichlorphenamide
• Dihydroergotamine
• Influenza Virus Vaccine, Live
• Ketorolac
• Linezolid
• Potassium Citrate
• Rasagiline
• Riociguat
• Selegiline
• Tranylcypromine
• Viloxazine

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.

• Abciximab
• Acarbose
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Acetazolamide
• Alclometasone
• Aldosterone
• Alfentanil
• Alipogene Tiparvovec
• Almotriptan
• Alteplase, Recombinant
• Amantadine
• Amcinonide
• Amifampridine
• Amikacin
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amphotericin B
• Amtolmetin Guacil
• Amygdalin
• Anagrelide
• Anisindione
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bacitracin
• Balsalazide
• Beclomethasone
• Bemetizide
• Bemiparin
• Benazepril
• Bendroflumethiazide
• Benzhydrocodone
• Benzphetamine

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.

• Ethanol
• 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:

• Alcohol abuse—Acetaminophen-containing medicines increase the chance of liver damage

• Asthma, allergies, and nasal polyps, history of, or
• Asthma attacks—Taking a salicylate-containing medicine may cause an allergic reaction in which breathing becomes difficult; also, although antihistamines open tightened bronchial passages, other effects of the antihistamines may cause secretions to become thick so that during an asthma attack it might be difficult to cough them up

• Type 2 diabetes mellitus—The decongestant in this medicine may put the patient with diabetes at a greater risk of having heart or blood vessel disease

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Some of the effects of antihistamines may cause urinary problems to get worse

• Glaucoma—A slight increase in inner eye pressure may occur

• Gout—Aspirin- or sodium salicylate-containing medicine may make the gout worse and reduce the benefit of the medicines used for gout

• Heart or blood vessel disease or
• High blood pressure—The decongestant in this medicine may cause the blood pressure to increase and may also speed up the heart rate; also, caffeine-containing medicine, if taken in large amounts, may have a similar effect on the heart

• Hemophilia or other bleeding problems—Aspirin- or sodium salicylate-containing medicine increases the chance of bleeding

• Hepatitis or other liver disease—There is a greater chance of side effects because the medicine is not broken down and may build up in the body; also, if liver disease is severe there is a greater chance that aspirin-containing medicine may cause bleeding

• Kidney disease (severe)—The kidneys may be affected, especially if too much of this medicine is taken for a long time

• Overactive thyroid—If the overactive thyroid has caused a fast heart rate, the decongestant in this medicine may cause the heart rate to speed up further

• Stomach ulcer or other stomach problems—Salicylate-containing medicine may make the ulcer worse or cause bleeding of the stomach

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

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

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

More common

• 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

More common

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

Less common

• 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