CPM-PSE DM Drops

Do not exceed recommended dosage.

Do not use this product under 4 years of age.

Do not use this product in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has a breathing problem such as chronic bronchitis, glaucoma, a persistent or chronic cough such that occurs with asthma, a cough that occurs with too much phlegm (mucus), heart disease, high blood pressure, thyroid disease, diabetes mellitus.

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers.

When using this product excitability may occur, especially in children; may cause marked drowsiness; sedatives and tranquilizers may increase drowsiness.

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur; cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. New symptoms occur.

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE1 AND ADMINISTRATION

Administer each dose four times per day using provided dropper. Do not exceed recommended dosage.

Children 6 to under 12 years

2 dropperfuls (2 mL) every 4-6 hours, not to exceed 4 doses (8 dropperfuls) per 24 hours.

Children under 6 years of age

consult a physician.

Also contains the following inactive ingredients (in alphabetical order): Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Grape flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Store at controlled room temperature 15°-30°C (59°-86°F).

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant cap.

Manufactured for:
TRIGEN
LABORATORIES
Sayreville, NJ 08872

Rev. 03/10

Applies to chlorpheniramine / dextromethorphan / pseudoephedrine: oral liquid, oral syrup

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to chlorpheniramine / dextromethorphan / pseudoephedrine: oral liquid, oral suspension extended release, oral tablet chewable

Nervous system

Nearly all patients treated with chlorpheniramine experience drowsiness. This drowsiness may subside in some patients with extended use.

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.[Ref]

Nervous system side effects of chlorpheniramine have included drowsiness in 75% or more of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine.

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Other side effects such as excitation, mental confusion, and opioid like respiratory depression have been rare and occurred at higher dosages. In some cases of abuse, patients experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects of chlorpheniramine have included dry mouth and constipation in up to one-third of treated patients.

Gastrointestinal side effects of dextromethorphan have included stomach upset.

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients.[Ref]

Cardiovascular

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (simulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Cardiovascular side effects of chlorpheniramine have included hypotension, tachycardia, and palpitations.

Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]

Ocular

Ocular effects of chlorpheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Genitourinary

Genitourinary side effects of chlorpheniramine have included dysuria, urinary hesitancy, and a decreased urine flow. In rare cases, the anticholinergic effect of chlorpheniramine has precipitated acute urinary retention.[Ref]

Hematologic

Hematologic side effects of chlorpheniramine have included bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]

A fatal case of agranulocytosis has been reported in a patient taking chlorpheniramine, pseudoephedrine, acetaminophen, dextromethorphan, phenylpropanolamine, and aspirin. Chlorpheniramine was felt to be the cause.[Ref]

Hypersensitivity

Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.

Hypersensitivity side effects of pseudoephedrine have included fixed-drug eruptions.[Ref]

Some side effects of CPM-PSE DM Drops may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.