Pyrichlor PE

Sugar Free • Alcohol Free

Phenylephrine Hydrochloride

Phenylephrine acts predominantly by a direct action on alpha (α) adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta (β) adrenergic receptors of the heart. Following oral administration, constriction of the blood vessels in the nasal mucosa may relieve nasal congestion. In therapeutic doses the drug causes little, if any, central nervous stimulation.

Pyrilamine Maleate

Pyrilamine is an antihistamine belonging to the ethylenediamine class. Pyrilamine is a highly effective H1 blocker, which possesses local anesthetic activity. Pyrilamine antagonizes most of the smooth muscle stimulating actions of histamine on the H1 receptors of the gastrointestinal tract, blood vessels and bronchial muscle. It also antagonizes the actions of histamines that result in increased capillary permeability and the formation of edema. Pyrilamine has a duration of action of 4 to 6 hours.

Chlorpheniramine Maleate

Chlorpheniramine Maleate is an antihistamine belonging to the alkylamine class. It possesses anticholinergic and sedative effects. It is considered one of the most effective and least toxic of the histamine antagonists. Chlorpheniramine is an H1 receptor antagonist. It antagonizes many of the pharmacological actions of histamine. Chlorpheniramine has a duration of action of 4 to 6 hours.

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. Antihistamines should be used with considerable caution in pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction. Sympathomimetic amines should be used with 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.

May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.

May cause excitability especially in children.

Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.

General

Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension, hyperactivity to ephedrine.

Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Information To Patients

Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Patients should be warned accordingly.

Pregnancy

Animal reproduction studies have not been conducted with this product. It is unknown whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction. This product should be given to a pregnant woman only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers

Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines.

Pediatric Use

This product is not indicated for use in children under 6 years old. Antihistamines may diminish mental alertness; in young children, they may produce paradoxical excitation.

Geriatric Use

The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans.

MAO inhibitors (or for 14 days after stopping MAOI therapy), and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines. Beta-adrenergic blockers and MAO inhibitors (or for 14 days after stopping MAOI therapy), may potentiate the pressor effect of sympathomimetics. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of sympathomimetics. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect.

Breckenridge
Pharmaceuticals, Inc.

NDC 51991-624-16

Pyrichlor PE™
Liquid

Antihistamine/Decongestant

• Sugar Free
• Alcohol Free

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

INACTIVE INGREDIENTS: Sodium Benzoate,
Citric Acid, Saccharin Sodium, Sorbitol Solution,
Glycerin, FD&C Red No. 40, FD&C Blue No. 1
Grape Flavor, Purified Water.

Rx Only

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