Pyril DM Suspension

Pyril DM Suspension is an antihistamine/ nasal decongestant/antitussive combination for oral administration as a suspension. Each 5 mL (one teaspoonful) of the grape-flavored, purple-colored suspension for oral administration contains:

Inactive ingredients: Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sucralose, monoammonium glycyrrhizinate, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate.

Pyril DM Suspension is indicated for the symptomatic relief of coryza, nasal congestion, and cough associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.

The most common effects associated with antihistamines have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines, sympathomimetics, and antitussives have been rare. Other adverse reactions may include:

Dermatologic - urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular - hypotension, hypertension, cardiac arrhythmias, palpitations.

Central Nervous System (CNS) - disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria.

Genitourinary - urinary frequency, difficult urination.

Gastrointestinal - epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory - tightness of chest and wheezing, shortness of breath.

Hematologic - hemolytic anemia, thrombocytopenia, agranulocytosis.

Pyril DM Suspension

Administer the recommended dose every 8 hours. Adults and Children over 12 years of age – 5 to 10 mL (1 to 2 teaspoonfuls); 6 to 12 years of age – 5 mL (1 teaspoonful); 2 to 6 years of age – 2.5 mL (1/2 teaspoonful); Under 2 years of age – Consult a physician.

NOTE: The maleate salt of pyrilamine, the hydrochloride salt of phenylephrine, and the hydrobromide salt of dextromethorphan are provided in a suspension by means of a patented manufacturing process.

MACOVEN
PHARMACEUTICALS, LLC

NDC 44183-210-16

PYRIL DM

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

SUSPENSION

Rx only

16 fl. oz. (473mL)

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.