Poly Hist Pd Recall
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Questions & Answers
Side Effects & Adverse Reactions
Pyrilamine Maleate and Chlorpheniramine 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. Chlorpheniramine Maleate has additional effects with
alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers) Patients should be warned about engaging
in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc.
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, indomethacin or with beta blockers
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. Therefore,
safe use of a short-acting sympathomimetic should be demonstrated in the individual elderly patient before
considering the use of a sustained-release formulation. Discontinue use if adverse reaction(s) occur.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Poly Hist PD is indicated for symptomatic relief of seasonal and perennial allergic rhinitis, and vasomotor rhinitis.
History
There is currently no drug history available for this drug.
Other Information
Antihistamine / Decongestant
Sugar Free / Alcohol Free / Dye Free
DESCRIPTION: POLY HIST PD is a sugar free, alcohol free, dye free, clear and colorless liquid with a
bubble gum odor and flavor. Each 5 mL (1 teaspoonful) contains:
Pyrilamine Maleate.................... 12.5 mg
Chlorpheniramine Maleate........... 2 mg
Phenylephrine HCl...................... 7.5 mg
Pyrilamine Maleate is an antihistamine that occurs as a white crystalline powder, usually having a faint odor.
It is very soluble in water, freely soluble in alcohol and chloroform, and slightly soluble in ether and benzene.
The chemical name is 1,2-Ethanediamine, N-[(4-methoxyphenyl)methyl]-N', N'dimethyl-N-2-pyridinyl-, (Z)-2-
butenedioate (1:1). Its structural formula is as follows:
Chlorpheniramine Maleate is an antihistaminic that occurs as a white, odorless crystalline powder. Its solutions
have a pH between 4 and 5. It is freely soluble in water, soluble in alcohol and chloroform, and slightly soluble
in ether and benzene. The chemical name is 2-Pyridinepropanamine, gamma-(4-chlorophenyl)-N,N-dimethyl-,
(Z)-2-butenedioate (1:1). Its structural formula is as follows:
Phenylephrine hydrochloride is an adrenergic that occurs as white or practically white, odorless crystals, having
a bitter taste. It is freely soluble in water and alcohol. It is affected by light. The chemical name is benzenemethanol, 3-hydroxy-alpha[(methylamino)methyl]-, hydrochloride (R)-. Its structural formula is as follows:
Inactive ingredients:
Propylene glycol, sorbitol, glycerin, sodium saccharin, purified water, and bubble gum flavoring.
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