Triplex DM

Antihistamine/Antitussive/Decongestant
Alcohol Free • Sugar Free • Dye Free

Pyrilamine Maleate

Antihistamines should be used with considerable caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. In infants and children especially, antihistamine overdosage may cause hallucinations, convulsions or death. As in adults, antihistamines may diminish mental alertness in children. Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances and machinery. Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor.

Phenylephrine Hydrochloride

Sympathomimetic amines should be used with considerable caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. DO NOT EXCEED RECOMMENDED DOSAGE. Hypertensive crisis could occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy), indomethacin or with betablockers and methyldopa. If a hypertensive crisis occurs, this drug should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling. The elderly (approximately sixty years or older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.

Do not exceed recommended doses. Discontinue use if adverse reaction(s) occur.

Dextromethorphan Hydrobromide

Adverse effects with dextromethorphan are rare, but nausea and/or other gastrointestinal disturbances, slight dizziness and drowsiness sometimes occur.

Pyrilamine Maleate

Possible side effects of antihistamines in general include: urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose and throat; cardiovascular effects (hypotension, headache, palpitation, tachycardia, extrasystoles); hematological effects (hemolytic anemia, thrombocytopenia, agranulocytosis); CNS disturbances (sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions); gastrointestinal effects (epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation); genitourinary effects (urinary frequency, difficult urination, urinary retention, early menses) and respiratory effects (thickening of bronchial secretions, tightness of the chest, wheezing and nasal stuffiness).

Phenylephrine Hydrochloride

Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness or nausea. Sympathomimetic amines have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Phenylephrine may cause precordial pain, respiratory distress, tremor, weakness, hypertension, restlessness, anxiety, nervousness and dizziness.

Adults and Children 12 years of age or older

1-2 teaspoonfuls every 4 to 6 hours or as directed by a physician, not to exceed 60 mg of Phenylephrine HCl in a 24-hour period.

Children 6 to 12 years of age

½ - 1 teaspoonful every 4 - 6 hours or as directed by a physician, not to exceed 30 mg of Phenylephrine HCl in a 24-hour period. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

Breckenridge
Pharmaceutical, Inc.

NDC 51991-493-16

Triplex™ DM
Liquid

• Sugar Free
• Alcohol Free
• Dye Free

Description: Each 5 mL (one teaspoonful) for oral
administration contains:

INACTIVE INGREDIENTS: Sodium Benzoate,
Citric Acid, Saccharin Sodium, Sorbitol Solution,
Glycerin, Grape Flavor, Purified Water.

Rx Only

Net Contents:
16 fl oz (One Pint) 473 mL

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.