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 capsule or extended-release tablet form of this medicine:

• Swallow the capsule or tablet whole.
• Do not crush, break, or chew before swallowing.
• If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

Dosing

The dose of these combination medicines will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses for these combinations. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of syrup that you take depends on the strength of the medicine. Also, the number of doses you take each day and the time between doses depend on whether you are taking a short-acting or a long-acting form of this medicine.

• For regular (short-acting) dosage forms (syrup, tablets, or chewable tablets):
  • For allergy and cold symptoms:
    • Adults and children 12 years of age and older 1 or 2 tablets or chewable tablets, or 1 to 2 teaspoonfuls of syrup every four to six hours.
    • Children up to 6 years of age Use and dose must be determined by your doctor.
    • Children 6 to 12 years of age 1 chewable tablet or 1 teaspoonful of syrup every four hours.
• For long-acting dosage forms (extended-release capsules or tablets):
  • For allergy and cold symptoms:
    • Adults and children 12 years of age and older 1 capsule or tablet every twelve hours.
    • Children up to 12 years of age Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, 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:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For antihistamine, decongestant, and anticholinergic combinations, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reactions to antihistamines or anticholinergics, or to amphetamine, dextroamphetamine (e.g., Dexedrine), ephedrine (e.g., Ephed II), epinephrine (e.g., Adrenalin), isoproterenol (e.g., Isuprel), metaproterenol (e.g., Alupent), methamphetamine (e.g., Desoxyn), norepinephrine (e.g., Levophed), phenylephrine (e.g., Neo-Synephrine), pseudoephedrine (e.g., Sudafed), or terbutaline (e.g., Brethine). Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy 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.

Breast-feeding 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.

Children 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.

Older adults 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.

Other medicines Although certain medicines should not be used together at all, in other cases 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 this medicine it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Appetite suppressants (diet pills), except fenfluramine (e.g., Pondimin), or
• Beta-adrenergic blocking agents (acebutolol [e.g., Sectral], atenolol [e.g., Tenormin], betaxolol [e.g., Kerlone], bisoprolol [e.g., Zebeta], carteolol [e.g., Cartrol], labetalol [e.g., Normodyne], metoprolol [e.g., Lopressor], nadolol [e.g., Corgard], oxprenolol [e.g., Trasicor], penbutolol [e.g., Levatol], pindolol [e.g., Visken], propranolol [e.g., Inderal], sotalol [e.g., Sotacor], timolol [e.g., Blocadren]) or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Digitalis medicine (heart medicine) or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert) Using any of these medicines together with a decongestant-containing combination may cause excessive stimulant side effects, such as difficulty in sleeping, heart rate problems, nervousness, and irritability

• Central nervous system (CNS) depressants Using these combinations with CNS depressants may worsen the effects (e.g., drowsiness) of CNS depressants or antihistamines

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) Taking an antihistamine, decongestant, and anticholinergic combination while you are taking or within 2 weeks of taking MAO inhibitors, may make the side effects of the antihistamines, decongestants, and anticholinergics more severe; these medicines should not be used together

• Other anticholinergics (medicine for abdominal or stomach spasms or cramps) Side effects of antihistamines or anticholinergics, such as dryness of mouth, may be more likely to occur

• Potassium chloride (e.g., Kay Ciel) Using this medicine with an anticholinergic-containing medicine may make gastrointestinal problems caused by potassium worse

• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil]) These medicines may increase or decrease the effect of the decongestant in this medicine

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) Effects, such as drowsiness, may be worsened; also, taking these medicines together may make some of the anticholinergic side effects, such as dryness of mouth, more severe

• 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

• Diabetes mellitus (sugar diabetes) 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