Antihistamine, decongestant, and anticholinergic 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 than adults to the effects of this medicine. Increases in blood pressure, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Also, when anticholinergics are given to children during hot weather, a rapid increase in body temperature may occur, which may lead to heat stroke. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be especially likely to cause severe side effects.

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 .

Confusion or memory loss, difficult and painful urination, dizziness, drowsiness, dryness of mouth, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of this medicine. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, eye pain may occur, which may be a sign of glaucoma.

For the individual ingredients of these combinations, the following apply:

• Antihistamines—Antihistamines have not been shown to cause problems in humans.
• Atropine—Studies on effects in pregnancy have not been done in humans. Atropine has not been shown to cause birth defects or other problems in animals.
• Hyoscyamine—Studies on effects in pregnancy have not been done in either humans or animals.
• Methscopolamine—Studies on effects in pregnancy have not been done in either humans or animals.
• Phenylephrine—Studies on birth defects have not been done in either humans or animals.
• Pseudoephedrine—Studies on birth defects have not been done in humans. Pseudoephedrine has not been shown to cause birth defects in animal studies. However, studies in animals have shown that pseudoephedrine causes a reduction in average weight, length, and rate of bone formation in the animal fetus.
• Scopolamine—Studies on effects in pregnancy have not been done in pregnant women. However, studies in animals at doses many times the human dose have shown that scopolamine causes a small increase in the number of fetal deaths.

Small amounts of antihistamines, decongestants, and anticholinergics may pass into the breast milk. Use is not recommended since this medicine may cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since this medicine tends to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some women.

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.

• Potassium Citrate

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.

• Amphetamine
• Dextroamphetamine
• Lisdexamfetamine
• Zavegepant

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.

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:

• Brain damage in children or
• Down syndrome or
• Dryness of mouth (severe and continuing) or
• Enlarged prostate or
• Fever or
• Glaucoma or
• Intestinal blockage or other intestinal problems or
• Kidney disease or
• Liver disease or
• Lung disease or
• Mental or emotional problems or
• Myasthenia gravis or
• Toxemia of pregnancy or
• Urinary tract blockage or difficult urination—These medicines may make these conditions worse.

• Type 2 diabetes mellitus—The decongestant in this medicine may put diabetic patients at greater risk of having heart or blood vessel disease.

• Heart or blood vessel disease or
• High blood pressure—The decongestant and anticholinergic in this medicine may cause the blood pressure to increase and may also speed up the heart rate.

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

For pseudoephedrine only

• Unusual nervousness, restlessness, or excitement

Rare

• Irregular or slow heartbeat
• mood or mental changes
• skin rash, hives, or itching
• sore throat and fever
• tightness in chest
• unusual bleeding or bruising
• unusual tiredness or weakness

More common

• Drowsiness
• nervousness
• restlessness
• thickening of mucus
• trouble in sleeping

Less common

• Blurred vision
• confusion
• difficult or painful urination
• dizziness
• dryness of mouth, nose, or throat
• fast or pounding heartbeat
• headache
• increased sweating
• loss of appetite
• nausea or vomiting
• nightmares
• ringing or buzzing in ears
• trembling
• unusual excitement, nervousness, restlessness, or irritability
• unusual paleness
• weakness