Decongestant and analgesic combinations (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. 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, especially if it contains:

• Decongestants (e.g., phenylephrine, pseudoephedrine)—Increases in blood pressure may be more likely to occur in children taking decongestants.
• Salicylates (e.g., aspirin)—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 its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in these children. 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.

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 .

The elderly are usually more sensitive to the effects of this medicine.

The occasional use of decongestant and analgesic combinations at the doses recommended on the label is not likely to cause problems in the fetus or in the newborn baby. However, for the individual ingredients of these combinations, the following information applies:

• Alcohol—Some of these combination medicines contain large amounts of alcohol. Too much use of alcohol during pregnancy may cause birth defects.
• —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).
• Ibuprofen—Studies on birth defects have not been done in humans. However, there is a chance that ibuprofen may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if it is taken regularly during the last few months of pregnancy.
• 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. However, when given to animals in high doses, pseudoephedrine did cause a decrease in average weight, length, and rate of bone formation in the animal fetus.
• Salicylates (e.g., aspirin)—Studies on birth defects in humans have been done with aspirin, but not with salicylamide. Although salicylates have been shown to cause birth defects in animals, they have not been shown to cause birth defects in humans.

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 and 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 reported 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.
• 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
• Clorgyline
• Defibrotide
• Dichlorphenamide
• Dihydroergotamine
• Fezolinetant
• Influenza Virus Vaccine, Live
• Iproniazid
• Isocarboxazid
• Ketorolac
• Linezolid
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Riociguat
• Selegiline
• Sibutramine
• 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
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amcinonide
• Amifampridine
• Amikacin
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amphotericin B
• Amtolmetin Guacil
• Anagrelide
• Anisindione
• Apixaban
• Ardeparin
• Argatroban
• Asciminib
• Aspirin
• Bacitracin
• Balsalazide
• Beclomethasone
• Bemetizide
• Bemiparin
• Benazepril
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bisacodyl
• Bismuth Subsalicylate

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 medicine increases the chance of liver damage.

• Anemia—Taking aspirin-, salicylamide-, or ibuprofen-containing medicine may make the anemia worse.

• Asthma, allergies, and nasal polyps, history of—Taking salicylate- or ibuprofen-containing medicine may cause an allergic reaction in which breathing becomes difficult.

• Diabetes mellitus (sugar diabetes)—The decongestant in this medicine may put the patient with diabetes at a greater risk of having heart or blood vessel disease.

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

• Hepatitis or other liver disease—Liver disease increases the 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, and that ibuprofen-containing medicine may cause serious kidney damage.

• 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 increase the heart rate; ibuprofen-containing medicine may cause the blood pressure to increase.

• Hemophilia or other bleeding problems—Aspirin- or ibuprofen-containing medicine increases the chance of bleeding.

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

• Mental illness (history of)—The decongestant in this medicine may increase the chance of mental side effects.

• Overactive thyroid—If an 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- or ibuprofen-containing medicine may make the ulcer worse or cause bleeding of the stomach.

• Systemic lupus erythematosus (SLE)—Ibuprofen-containing medicine may put the patient with SLE at a greater risk of having unwanted effects on the central nervous system and/or kidneys.

• Ulcers, sores, or white spots in the mouth—This may be a sign of a serious side effect of ibuprofen-containing medicine; if you already have ulcers or sores in the mouth you and your doctor may not be able to tell when this side effect occurs.

For all combinations

• Convulsions (seizures)
• dizziness or light-headedness (severe)
• fast, slow, or irregular heartbeat
• hallucinations (seeing, hearing, or feeling things that are not there)
• headache (continuing and severe)
• increased sweating
• mood or mental changes
• nausea or vomiting (severe or continuing)
• nervousness or restlessness (severe)
• shortness of breath or troubled breathing
• stomach cramps or pain (severe or continuing)
• swelling or tenderness in the upper abdomen or stomach area
• trouble in sleeping

For acetaminophen-containing only

• Diarrhea
• loss of appetite

For aspirin- or salicylamide-containing only

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

More common

• Nausea, vomiting, or stomach pain (mild—for combinations containing aspirin or ibuprofen)

Less common or rare

• Bloody or black, tarry stools
• bloody or cloudy urine
• blurred vision or any changes in vision or eyes
• changes in facial skin color
• changes in hearing
• changes or problems with urination
• difficult or painful urination
• fever
• headache, severe, with fever and stiff neck
• increased blood pressure
• muscle cramps or pain
• skin rash, hives, or itching
• sores, ulcers, or white spots on lips or in mouth
• swelling of face, fingers, feet, or lower legs
• swollen and/or painful glands
• unexplained sore throat and fever
• 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

• Heartburn or indigestion (for medicines containing salicylate or ibuprofen)
• nervousness or restlessness

Less common

• Drowsiness (for medicines containing salicylamide)