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Pyril DM Suspension

Generic Name: phenylephrine hydrochloride, pyrilamine maleate, and dextromethorphan hydrobromide
Dosage Form: oral suspension

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Pyril DM
Suspension

Rx Only

Pyril DM Suspension Description

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:

Phenylephrine HCl 5 mg
Pyrilamine Maleate 16 mg
Dextromethorphan HBr 15 mg

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 - Clinical Pharmacology

Pyril DM Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine and the antitussive effect of dextromethorphan.

PHENYLEPHRINE

Phenylephrine is a decongestant which is a potent postsynaptic α-receptor agonist with little effect on β receptors of the heart. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Phenylephrine has no effect on β-adrenergic receptors of the bronchi or peripheral blood vessels.

Phenylephrine has a mild central stimulant effect.

PYRILAMINE

Pyrilamine is an antihistamine, H1 receptor blocking agent belonging to the ethylenediamine class of antihistamines. H1-blocking drugs inhibit the actions of histamine on smooth muscle, capillary permeability, and can both stimulate and depress the central nervous system.

Pyrilamine also possesses anticholinergic and sedative properties.

DEXTROMETHORPHAN

Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity.

Indications and Usage for Pyril DM Suspension

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.

Contraindications

Pyril DM Suspension is contraindicated in patients sensitive to any of the ingredients or related compounds. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds).

Pyril DM Suspension should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see "PRECAUTIONS-DRUG INTERACTIONS").

Warnings

This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines shoud be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck.

Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

Precautions

GENERAL

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients, and therefore should be used with caution. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or narrow angle glaucoma. Dextromethorphan should be used with caution in sedated patients, and in patients confined to the supine position.

INFORMATION FOR PATIENTS

Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAO inhibitor drug. If patients are uncertain whether a prescription drug contains an MAO inhibitor, they should be instructed to consult a health professional before taking this product.

DRUG INTERACTIONS

MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea, myoclonic leg jerks, and coma following coadministration of MAO inhibitors and dextromethorphan. Thus, concomitant administration of Pyril DM Suspension and MAO inhibitors should be avoided (see " CONTRAINDICATIONS").

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No long-term animal studies have been performed with Pyril DM Suspension.

PREGNANCY

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Pyril DM Suspension. It is also not known whether Pyril DM Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyril DM Suspension should be given to a pregnant woman only if clearly needed.

LABOR AND DELIVERY

Administration of phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

NURSING MOTHERS

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Pyril DM Suspension should not be administered to a nursing mother.

Adverse Reactions

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.

Overdosage

SIGNS AND SYMPTOMS

May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent. Dextromethorphan may produce central excitement and mental confusion. Very high doses of dextromethorphan may produce respiratory depression.

TREATMENT

Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children, and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

Pyril DM Suspension Dosage and Administration

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.

How is Pyril DM Suspension Supplied

Pyril DM Suspension: is available in a grape-flavored, purple-colored suspension.

NDC No.: 44183-210-16 – 16 fl. oz. bottles.

Store at controlled room temperature, 20°-25°C (68°-77°F).

Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.

Patent Protected

Rx Only

Manufactured for:
Macoven Pharmaceuticals, LLC
Magnolia, TX 77354

Int 3/09
547-60416-2

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

MACOVEN
PHARMACEUTICALS, LLC

NDC 44183-210-16

PYRIL DM

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

Pyrilamine Maleate 16 mg
Phenylephrine HCl 5 mg
Dextromethorphan HBr 15 mg

SUSPENSION

Rx only

16 fl. oz. (473mL)

PYRIL DM 
phenylephrine hydrochloride, pyrilamine maleate, and dextromethorphan hydrobromide suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44183-210
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 16 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
GLYCERIN  
GRAPE  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
WATER  
SUCRALOSE  
GLYCYRRHIZIN, AMMONIATED  
SODIUM BENZOATE  
SODIUM CITRATE  
SUCROSE  
XANTHAN GUM  
TANNIC ACID  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:44183-210-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/04/2010
Labeler - Macoven Pharmaceuticals (832591965)
Revised: 12/2010
 
Macoven Pharmaceuticals
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