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Pyril D Suspension

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

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Pyril D
Suspension

Rx Only

Pyril D Suspension Description

Pyril D Suspension is an antihistamine/ nasal decongestant 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

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

Pyril D Suspension - Clinical Pharmacology

Pyril D Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine.

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.

Indications and Usage for Pyril D Suspension

Pyril D Suspension is indicated for the symptomatic relief of the coryza and nasal congestion 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 D 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 D 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 should 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.

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.

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. Thus, concomitant administration of Pyril D Suspension and MAO inhibitors should be avoided (see "CONTRAINDICATIONS").

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

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

PREGNANCY

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Pyril D Suspension. It is also not known whether Pyril D Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyril D 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 D 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 or sympathomimetics 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.

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 D Suspension Dosage and Administration

Pyril D Suspension

Administer the recommended dose every 6 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 (½ teaspoonful); Under 2 years of age – Consult a physician.

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

How is Pyril D Suspension Supplied

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

NDC No.: 44183-208-16 – 16 fl. oz. bottles.

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

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

Rx Only

Manufactured for:
Macoven Pharmaceuticals, LLC
Magnolia, TX 77354

Patent Protected

Int 3/09
547-59416-2

PRINCIPAL DISPLAY PANEL - 473mL Bottle Label

MACOVEN
PHARMACEUTICALS, LLC

NDC 44183-208-16

PYRIL D

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

Pyrilamine Maleate 16 mg
Phenylephrine HCl 5 mg

SUSPENSION

Rx only

16 fl. oz. (473mL)

PYRIL D 
phenylephrine hydrochloride and pyrilamine maleate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44183-208
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
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  
SACCHARIN SODIUM  
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:44183-208-16 473 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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