PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE- promethazine hydrochloride and phenylephrine hydrochloride syrup

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Hi-Tech Pharmacal Co., Inc.
INN (International Name):
PROMETHAZINE HYDROCHLORIDE
Composition:
PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. 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). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).
Product summary:
This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL). Keep tightly closed. Protect from light. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Made in U.S.A. Rev. 802:01 08/16
Authorization status:
Abbreviated New Drug Application
Authorization number:
50383-802-04, 50383-802-16

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE-

promethazine hydrochloride and phenylephrine hydrochloride syrup

Hi-Tech Pharmacal Co., Inc.

----------

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

SYRUP

Rx only

DESCRIPTION

Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup is a yellow-orange colored, fruit

flavored syrup. Each 5 mL (one teaspoonful), for oral administration contains: Promethazine

hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg. Alcohol 7%.

Inactive Ingredients: Sucrose syrup, sodium benzoate, sodium citrate, propylene glycol, citric acid,

ascorbic acid, methylparaben, propylparaben, FD&C Yellow No. 6, natural tangerine extract and

purified water.

Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-

(Dimethylamino)propyl] phenothiazine monohydrochloride.

Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder

which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely

soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C

H N S HCl, and

the following structural formula:

Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m-

Hydroxy-α-[(methyl amino)methyl]benzyl alcohol hydrochloride. It occurs as white or nearly white

crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is

subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a

molecular formula of C H NO HCl, and the following structural formula:

CLINICAL PHARMACOLOGY

Promethazine:

Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic

phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this

configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist

properties.

Promethazine is an H receptor blocking agent. In addition to its antihistaminic action, it provides

clinically useful sedative and antiemetic effects.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20

minutes after oral administration and generally last four to six hours, although they may persist as long

as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of

promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

Phenylephrine:

Phenylephrine is a potent postsynaptic-α-receptor agonist with little effect on β-receptors of the heart.

Phenylephrine has no effect on β-adrenergic receptors of the bronchi or peripheral blood vessels. 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.

Therapeutic doses of phenylephrine mainly cause vasoconstriction. Phenylephrine increases resistance

and, to a lesser extent, decreases capacitance of blood vessels. Total peripheral resistance is increased,

resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually

increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur

following topical application or infiltration of phenylephrine into tissues. The main effect of

phenylephrine on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in

doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of

the heart, causing arrhythmias. Cardiac output is decreased slightly. Phenylephrine increases the work

of the heart by increasing peripheral arterial resistance.

Phenylephrine has a mild central stimulant effect.

Following oral administration or topical application of phenylephrine to the mucosa, constriction of

blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds.

Following oral administration, nasal decongestion may occur within 15 or 20 minutes and may persist

for up to 4 hours.

Phenylephrine is irregularly absorbed from and readily metabolized in the gastrointestinal tract.

Phenylephrine is metabolized in the liver and intestine by monoamine oxidase. The metabolites and their

route and rate of excretion have not been identified. The pharmacologic action of phenylephrine is

terminated at least partially by uptake of the drug into tissues.

INDICATIONS AND USAGE

Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary

relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the

common cold.

CONTRAINDICATIONS

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to

have had an idiosyncratic reaction to promethazine or to other phenothiazines.

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).

Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those

receiving a monoamine oxidase inhibitor (MAOI).

WARNINGS

WARNING

PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC

PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR

FATAL RESPIRATORY DEPRESSION.

POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING

FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE

HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A

WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE

HYDROCHLORIDE HAVE

RESULTED IN RESPIRATORY DEPRESSION IN THESE

PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE

HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT

IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE

HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND

OLDER

AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH

RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

Promethazine

CNS Depression: Promethazine may impair the mental and/or physical abilities required for the

performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The

impairment may be amplified by concomitant use of other central-nervous-system depressants such as

alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics,

tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in

reduced dosage in the presence of promethazine HCl (see PRECAUTIONS-Information for Patients

and Drug Interactions).

Respiratory Depression: Promethazine may lead to potentially fatal respiratory depression.

Use of Promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea)

should be avoided.

Lower Seizure Threshold: Promethazine may lower seizure threshold. It should be used with caution in

persons with seizure disorders or in persons who are using concomitant medications, such as narcotics

or local anesthetics, which may also affect seizure threshold.

Bone-Marrow Depression: Promethazine should be used with caution in patients with bone-marrow

depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has

been used in association with other known marrow-toxic agents.

Neuroleptic Malignant Syndrome: A potentially fatal symptom complex sometimes referred to as

Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone

or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle

rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure,

tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is

important to identify cases where the clinical presentation includes both serious medical illness (e.g.,

pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and

symptoms (EPS). Other important considerations in the differential diagnosis include central

anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of promethazine HCl,

antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic

treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for

which specific treatments are available. There is no general agreement about specific pharmacological

treatment regimens for uncomplicated NMS.

Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine

HCl should be carefully considered.

Use in Pediatric Patients:

PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC

PATIENTS LESS THAN TWO YEARS OF CAUTION SHOULD BE EXERCISED WHEN

ADMINISTERING PROMETHAZINE PRODUCTS TO PEDIATRIC PATIENTS 2 YEARS OF

AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY

DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED

WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS

AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING,

WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT

ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY

DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND

SOMETIMES DEATH, IN PEDIATRIC PATIENTS.

ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED

VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO

PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL

SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE

HYDROCHLORIDE ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF

UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE’S SYNDROME.

THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC

PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE’S SYNDROME OR

OTHER HEPATIC DISEASES.

Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric

patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred

with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric

patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias

with the use of promethazine HCl.

Other Considerations: Administration of promethazine has been associated with reported cholestatic

jaundice.

Phenylephrine

Because phenylephrine is an adrenergic agent, it should be given with caution to patients with thyroid

diseases, diabetes mellitus, and heart disease or those receiving tricyclic antidepressants.

Men with symptomatic, benign prostatic hypertrophy can experience urinary retention when given oral

nasal decongestants.

Phenylephrine can cause a decrease in cardiac output, and extreme caution should be used when

administering the drug parenterally or orally to patients with arteriosclerosis, to elderly individuals,

and/or to patients with initially poor cerebral or coronary circulation.

Phenylephrine should be used with caution in patients taking diet preparations, such as amphetamines or

phenylpropanolamine, because synergistic adrenergic effects could result in serious hypertensive

response and possible stroke.

PRECAUTIONS

Animal reproduction studies have not been conducted with the drug combination–promethazine and

phenylephrine. It is not known whether this drug combination can cause fetal harm when administered to

a pregnant woman or can affect reproduction capacity. Promethazine and phenylephrine should be given

to a pregnant woman only if clearly needed.

General

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle

glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck

obstruction.

Promethazine should be used cautiously in persons with cardiovascular disease or impairment of liver

function.

Phenylephrine should be used with caution in patients with cardiovascular disease, particularly

hypertension.

Information for Patients

Promethazine and phenylephrine may cause marked drowsiness or may impair the mental and/or physical

abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or

operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is

known that they do not become drowsy or dizzy from promethazine and phenylephrine therapy. Children

should be supervised to avoid potential harm in bike riding or in other hazardous activities.

The concomitant use of alcohol or other central nervous system depressants, including narcotic

analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or

their dosage reduced.

Patients should be advised to report any involuntary muscle movements.

Avoid prolonged exposure to the sun.

Drug Interactions

Promethazine

CNS Depressants: Promethazine may increase, prolong, or intensify the sedative action of other central-

nervous system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics,

narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such

agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl.

When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least

one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be

individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness

and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control

of the pain.

Epinephrine: Because of the potential for promethazine to reverse epinephrine’s vasopressor effect,

epinephrine should NOT be used to treat hypotension associated with promethazine overdose.

Anticholinergics: Concomitant use of other agents with anticholinergic properties should be undertaken

with caution.

Monoamine oxidase inhibitors (MAOI): Drug interactions, nincluding an increased incidence of

extrapyramidal effects, have been reported when some MAOI and phenothiazines are used

concomitantly.

Phenylephrine

Drug

Effect

Phenylephrine with prior administration of

monoamine oxidase inhibitors (MAOI).

Cardiac pressor response potentiated. May cause

acute hypertensive crisis.

Phenylephrine with tricyclic antidepressants.

Pressor response increased.

Phenylephrine with ergot alkaloids.

Excessive rise in blood pressure.

Phenylephrine with bronchodilator

sympathomimetic agents and with epinephrine or

other sympathomimetics.

Tachycardia or other arrhythmias may occur.

Phenylephrine with atropine sulfate.

Reflex bradycardia blocked; pressor response

enhanced.

Phenylephrine with prior administration of

propranolol or other ß-adrenergic blockers.

Cardiostimulating effects blocked.

Phenylephrine with prior administration of

phentolamine or other α-adrenergic blockers.

Pressor response decreased.

Phenylephrine with diet preparations, such as

amphetamines or phenylpropanolamine.

Synergistic adrenergic response.

Drug/Laboratory Test Interactions

The following laboratory tests may be affected in patients who are receiving therapy with promethazine

hydrochloride.

Pregnancy Tests:

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in

false-negative or false-positive interpretations.

Glucose Tolerance Test:

An increase in blood glucose has been reported in patients receiving promethazine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Promethazine:

Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine,

nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of

fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

Phenylephrine:

A study which followed the development of cancer in 143,574 patients over a four-year period

indicated that in 11,981 patients who received phenylephrine (systemic or topical), there was no

statistically significant association between the drug and cancer at any or all sites.

Long-term animal studies have not been performed to assess the carcinogenic potential of

phenylephrine, nor are there other animal or human data concerning mutagenicity.

A study of the effects of adrenergic drugs on ovum transport in rabbits indicated that treatment with

phenylephrine did not alter incidence of pregnancy; the number of implantations was significantly

reduced when high doses of the drug were used.

Pregnancy

Teratogenic Effects - Pregnancy category C.

Promethazine:

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg

of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended

total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug

is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in

rats.

Specific studies to test the action of the drug on parturition, lactation, and development of the animal

neonate were not done, but a general preliminary study in rats indicated no effect on these parameters.

Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological

effects of histamine in the rodent do not parallel those in man. There are no adequate and well-

controlled studies of promethazine in pregnant women.

Phenylephrine:

A study in rabbits indicated that continued moderate overexposure to phenylephrine (3 mg/day) during

the second half of pregnancy (22nd day of gestation to delivery) may contribute to perinatal wastage,

prematurity, premature labor, and possibly fetal anomalies; when phenylephrine (3 mg/day) was given to

rabbits during the first half of pregnancy (3rd day after mating for seven days), a significant number

gave birth to litters of low birth weight. Another study showed that phenylephrine was associated with

anomalies of aortic arch and with ventricular septal defect in the chick embryo.

Promethazine and phenylephrine should be used during pregnancy only if the potential benefit justifies

the potential risk to the fetus.

Nonteratogenic Effects –

Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet

aggregation in the newborn.

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.

See also “Nonteratogenic Effects.”

Nursing Mothers

It is not known whether promethazine or phenylephrine are excreted in human milk.

Caution should be exercised when promethazine and phenylephrine is administered to a nursing woman.

Pediatric Use

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

SYRUP IS CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO

YEARS OF AGE. (see WARNINGS-Black Box Warning and Use in Pediatric Patients).

Promethazine hydrochloride and phenylephrine hydrochloride syrup should be used with caution in

pediatric patients 2 years of age and older (see WARNINGS-Use in Pediatric Patients)

Geriatric Use

Clinical studies of promethazine hydrochloride and phenylephrine hydrochloride syrup did not include

sufficient numbers of subjects aged 65 and over to determine whether they respond differently from

younger subjects. Other reported clinical experience has not identified differences in responses

between the elderly and younger patients. In general, dose selection for an elderly patient should be

cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of

decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should

be started on low doses of promethazine hydrochloride and phenylephrine hydrochloride syrup and

observed closely.

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-

9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Promethazine

Central Nervous System - Drowsiness is the most prominent CNS effect of this drug. Sedation,

somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as

oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue,

euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like

states, hysteria. Hallucinations have also been reported.

Cardiovascular - Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic - Dermatitis, photosensitivity, urticaria.

Hematologic - Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal - Dry mouth, nausea, vomiting, jaundice.

Respiratory - Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially

fatal). (See WARNINGS-Promethazine; Respiratory Depression.)

Other - Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been

reported. (See WARNINGS-Promethazine; Neuroleptic Malignant Syndrome.)

Paradoxical Reactions - Hyperexcitability and abnormal movements have been reported in patients

following a single administration of promethazine HCl. Consideration should be given to the

discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory

depression, nightmares, delirium, and agitated behavior have also been reported in some of these

patients.

Phenylephrine

Nervous System – Restlessness, anxiety, nervousness and dizziness.

Cardiovascular – Hypertension (see “WARNINGS”).

Other – Precordial pain, respiratory distress, tremor, and weakness.

OVERDOSAGE

Promethazine

Signs and symptoms of overdosage with promethazine HCI range from mild depression of the central

nervous system and cardiovascular system to profound hypotension, respiratory depression,

unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia,

athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur.

A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally,

mcharacterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal

symptoms, may occur.

Phenylephrine

Signs and symptoms of overdosage with phenylephrine include hypertension, headache, convulsions,

cerebral hemorrhage, and vomiting. Ventricular premature beats and short paroxysms of ventricular

tachycardia may also occur. Headache may be a symptom of hypertension. Bradycardia may also be seen

early in phenylephrine overdosage through stimulation of baroreceptors.

Treatment

The treatment of overdosage with promethazine and phenylephrine is essentially symptomatic and

supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including

respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal

orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should

be given to the reestablishment of adequate respiratory exchange through provision of a patent airway

and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions.

Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine

are not reversed by naloxone. Avoid analeptics which may cause convulsions.

Severe hypotension usually responds to the administration of norepinephrine or phenylephrine.

EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade

may further lower the blood pressure.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE AND ADMINISTRATION

Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for

children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients).

The recommended doses are given in the following table:

Adults And Children 12 Years And Over

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 6 To Under 12 Years Of Age

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 2 To Under 6 Years Of Age

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.

HOW SUPPLIED

This preparation is a yellow-orange colored, fruit flavored syrup. Each 5 mL (one teaspoonful)

contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7

percent, and is available in bottles of 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL).

Keep tightly closed. Protect from light.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Made in U.S.A.

Rev. 802:01 08/16

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

AKORN

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

SYRUP

6.25 mg/5 mg PER 5 mL

EACH 5 mL (ONE TEASPOONFUL) CONTAINS:

Promethazine Hydrochloride ………………………..6.25 mg

Phenylephrine Hydrochloride …………………………. 5 mg

Alcohol ………………………………………………….7%

USUAL DOSAGE: See accompanying package insert.

CAUTION: Maycause drowsiness. Alcohol may intensify this effect. Do not drive or

operatemachinery while taking this medication.

WARNING: Keep this and all drugs out of the reach of children. In case of accidental overdose,

seek professional assistance or contact a poison control center immediately.

Store at 20° -25°C (68°- 77°F) [see USP Controlled Room Temperature]. Keep tightly closed. Protect

from light.

Dispense in a tight, light-resistant container, as defined in the USP.

Rx only

16 fl oz (473 mL)

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE

HYDROCHLORIDE

promethazine hydrochloride and phenylephrine hydrochloride syrup

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:50 38 3-8 0 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PRO METHAZINE HYDRO CHLO RIDE (UNII: R6 1ZEH7I1I) (PROMETHAZINE -

UNII:FF28 EJQ 49 4)

PROMETHAZINE

HYDROCHLORIDE

6 .25 mg

in 5 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Hi-Tech Pharmacal Co., Inc.

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

YELLOW (yello w-o range)

S core

S hap e

S iz e

Flavor

FRUIT (natural tangerine extract)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 38 3-8 0 2-16

473 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /16 /20 15

2

NDC:50 38 3-8 0 2-0 4

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /16 /20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 6 75

0 6 /16 /20 15

Labeler -

Hi-T ech Pharmacal Co., Inc. (101196749)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hi-Tech Pharmacal Co ., Inc.

10 119 6 749

MANUFACTURE(50 38 3-8 0 2)

Revised: 8/2017

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