PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride tablet

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Ixtrih issa

Ingredjent attiv:
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)
Disponibbli minn:
STAT Rx USA LLC
INN (Isem Internazzjonali):
PROMETHAZINE HYDROCHLORIDE
Kompożizzjoni:
PROMETHAZINE HYDROCHLORIDE 25 mg
Rotta amministrattiva:
ORAL
Tip ta 'preskrizzjoni:
PRESCRIPTION DRUG
Indikazzjonijiet terapewtiċi:
Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients. Promethazine hydrochloride tablets are contraindicated for use in p
Sommarju tal-prodott:
Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted DAN DAN and 5307 supplied in: Bottles of 10 NDC # 16590-191-10 Bottles of 15 NDC # 16590-191-15 Bottles of 20 NDC # 16590-191-20 Bottles of 28 NDC # 16590-191-28 Bottles of 30 NDC # 16590-191-30 Bottles of 45 NDC # 16590-191-45 Bottles of 56 NDC # 16590-191-56 Bottles of 60 NDC # 16590-191-60 Bottles of 120 NDC # 16590-191-72 Bottles of 112 NDC # 16590-191-73 Bottles of 75 NDC # 16590-191-75 Bottles of 90 NDC # 16590-191-90 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Keep tightly closed. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Protect from light. Manufactured By: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: June 2009 190824 0609B Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA. 30501
L-istatus ta 'awtorizzazzjoni:
Abbreviated New Drug Application
Numru ta 'awtorizzazzjoni:
16590-191-10, 16590-191-15, 16590-191-20, 16590-191-28, 16590-191-30, 16590-191-45, 16590-191-56, 16590-191-60, 16590-191-72, 16590-191-73, 16590-191-75, 16590-191-90

PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride tablet

STAT Rx USA LLC

----------

Promethazine Hydrochloride Tablets USP

Revised: June 2009

Rx only

190824

DESCRIPTION

Promethazine hydrochloride is a racemic compound.

Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-

Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural

formula:

H N SHCl M.W. 320.88

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.

Each tablet, for oral administration, contains 25 mg or 50 mg of promethazine hydrochloride. In addition

each tablet contains the following inactive ingredients: dibasic calcium phosphate, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate and stearic acid.

Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous lactose.

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

Promethazine hydrochloride tablets are useful for:

Perennial and seasonal allergic rhinitis.

Vasomotor rhinitis.

Allergic conjunctivitis due to inhalant allergens and foods.

Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

Amelioration of allergic reactions to blood or plasma.

Dermographism.

Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute

manifestations have been controlled.

Preoperative, postoperative, or obstetric sedation.

Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.

Sedation in both children and adults, as well as relief of apprehension and production of light sleep

from which the patient can be easily aroused.

Active and prophylactic treatment of motion sickness.

Antiemetic therapy in postoperative patients.

CONTRAINDICATIONS

Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years

of age.

Promethazine hydrochloride tablets are 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.

WARNINGS

PROMETHAZINE HYDROCHLORIDE TABLETS USP 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.

CNS Depression

Promethazine hydrochloride tablets 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 hydrochloride tablets may lead to potentially fatal respiratory depression.

Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g.,

COPD, sleep apnea) should be avoided.

Lower Seizure Threshold

Promethazine hydrochloride tablets may lower seizure threshold. They 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 hydrochloride tablets 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 HYDROCHLORIDE TABLETS USP ARE CONTRAINDICATED FOR

USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE

HYDROCHLORIDE TABLETS 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 TABLETS ADMINISTRATION MAY BE CONFUSED WITH THE CNS

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

SYNDROME. THE USE OF PROMETHAZINE HCL TABLETS 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 tablets, in pediatric

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

with therapeutic doses and overdoses of promethazine 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 HCl has been associated with reported cholestatic jaundice.

PRECAUTIONS

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 hydrochloride tablets should be used cautiously in persons with cardiovascular disease

or with impairment of liver function.

Information for Patients

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

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

operating machinery. The use of alcohol or other central-nervous-system depressants such as

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

tricyclic antidepressants, and tranquilizers, may enhance impairment (see WARNINGS-CNS

Depression and PRECAUTIONS-Drug Interactions). Pediatric patients should be supervised to

avoid potential harm in bike riding or in other hazardous activities.

Patients should be advised to report any involuntary muscle movements.

Avoid prolonged exposure to the sun.

Drug Interactions

CNS Depressants - Promethazine hydrochloride tablets 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 hydrochloride tablets, 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 hydrochloride

tablets overdose.

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

with caution.

Monoamine Oxidase Inhibitors (MAOI) - Drug interactions, including an increased incidence of

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

concomitantly. This possibility should be considered with promethazine hydrochloride tablets.

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 falsepositive interpretations.

Glucose Tolerance Test

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

Pregnancy

Teratogenic Effects-Pregnancy Category C

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 hydrochloride tablets in pregnant women.

Promethazine hydrochloride tablets should be used during pregnancy only if the potential benefit

justifies the potential risk to the fetus.

Nonteratogenic Effects

Promethazine hydrochloride tablets administered to a pregnant woman within two weeks of delivery may

inhibit platelet aggregation in the newborn.

Labor and Delivery

Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE

AND ADMINISTRATION). Limited data suggest that use of promethazine during labor and delivery

does not have an appreciable effect on the duration of labor or delivery and does not increase the risk

of need for intervention in the newborn. The effect on later growth and development of the newborn is

unknown. (See also Nonteratogenic Effects.)

Nursing Mothers

It is not known whether promethazine HCl is excreted in human milk. Because many drugs are excreted

in human milk and because of the potential for serious adverse reactions in nursing infants from

promethazine hydrochloride tablets, a decision should be made whether to discontinue nursing or to

discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

PROMETHAZINE HYDROCHLORIDE TABLETS USP ARE CONTRAINDICATED FOR

USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black

Box Warning and Use in Pediatric Patients).

Promethazine hydrochloride tablets 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 formulations 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 tablets and observed closely.

ADVERSE REACTIONS

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 WARNINGSRespiratory Depression.)

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

reported. (See WARNINGS-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.

OVERDOSAGE

Signs and symptoms of overdosage with promethazine HCl 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-type reaction has been reported in children receiving single doses of 75 mg to 125 mg

orally, characterized by hyperexcitability and nightmares.

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

gastrointestinal symptoms — may occur.

Treatment

Treatment of overdosage 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 HCl are not reversed by

naloxone. Avoid analeptics which may cause convulsions.

The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied

by repositioning if indicated. In the event that vasopressors are considered for the management of

severe hypotension which does not respond to intravenous fluids and repositioning, the administration

of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED,

since its use in patients with partial adrenergic blockade may further lower the blood pressure.

Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine,

or barbiturates. Oxygen may also be administered.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE AND ADMINISTRATION

Promethazine Hydrochloride Tablets USP are contraindicated for children under 2 years of age

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

Allergy

The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and

on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will

usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the

smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25-mg doses

will control minor transfusion reactions of an allergic nature.

Motion Sickness

The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour

before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel,

it is recommended that 25 mg be given on arising and again before the evening meal. For children,

promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 to 25 mg twice daily, may be

administered.

Nausea and Vomiting

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see

WARNINGS-Use in Pediatric Patients).

The average effective dose of promethazine hydrochloride for the active therapy of nausea and

vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be

given parenterally (cf. Promethazine Injection) or by rectal suppository. 12.5- to 25-mg doses may be

repeated, as necessary, at 4- to 6-hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose

should be adjusted to the age and weight of the patient and the severity of the condition being treated.

For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average

dose is 25 mg repeated at 4- to 6-hour intervals, as necessary.

Sedation

This product relieves apprehension and induces a quiet sleep from which the patient can be easily

aroused. Administration of 12.5 to 25 mg promethazine hydrochloride by the oral route or by rectal

suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for

nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use

Promethazine hydrochloride in 12.5- to 25-mg doses for children and 50-mg doses for adults the night

before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication, children require doses of 0.5 mg per pound of body weight in

combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of

an atropine-like drug. Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced

dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5

to 25 mg in children and 25- to 50-mg doses in adults.

Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.

HOW SUPPLIED

Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted DAN DAN

and 5307 supplied in:

Bottles of 10 NDC # 16590-191-10

Bottles of 15 NDC # 16590-191-15

Bottles of 20 NDC # 16590-191-20

Bottles of 28 NDC # 16590-191-28

Bottles of 30 NDC # 16590-191-30

Bottles of 45 NDC # 16590-191-45

Bottles of 56 NDC # 16590-191-56

Bottles of 60 NDC # 16590-191-60

Bottles of 120 NDC # 16590-191-72

Bottles of 112 NDC # 16590-191-73

Bottles of 75 NDC # 16590-191-75

Bottles of 90 NDC # 16590-191-90

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

Keep tightly closed.

Store at 20-25°C (68-77°F). [See USP controlled room temperature.]

Protect from light.

Manufactured By:

Watson Pharma Private Ltd.

Verna, Salcette Goa 403 722 INDIA

Distributed By:

Watson Pharma, Inc.

Corona, CA 92880 USA

Revised: June 2009

190824

0609B

Relabeling and Repackaging by:

STAT Rx USA LLC

Gainesville, GA. 30501

PACKAGE LABEL - PROMETHAZINE 25 MG TABLETS

PROMETHAZINE HYDROCHLORIDE

promethazine hydrochloride tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:16 59 0 -19 1(NDC:0 59 1-530 7)

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

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

2 pieces

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

DAN;DAN;530 7

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:16 59 0 -19 1-10

10 in 1 BOTTLE, PLASTIC

2

NDC:16 59 0 -19 1-15

15 in 1 BOTTLE, PLASTIC

3

NDC:16 59 0 -19 1-20

20 in 1 BOTTLE, PLASTIC

4

NDC:16 59 0 -19 1-28

28 in 1 BOTTLE, PLASTIC

5

NDC:16 59 0 -19 1-30

30 in 1 BOTTLE, PLASTIC

6

NDC:16 59 0 -19 1-45

45 in 1 BOTTLE, PLASTIC

7

NDC:16 59 0 -19 1-56

56 in 1 BOTTLE, PLASTIC

8

NDC:16 59 0 -19 1-6 0

6 0 in 1 BOTTLE, PLASTIC

9

NDC:16 59 0 -19 1-72

120 in 1 BOTTLE, PLASTIC

10

NDC:16 59 0 -19 1-73

112 in 1 BOTTLE, PLASTIC

11

NDC:16 59 0 -19 1-75

75 in 1 BOTTLE, PLASTIC

12

NDC:16 59 0 -19 1-9 0

9 0 in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 8 3426

0 9 /19 /19 73

Labeler -

ST AT Rx USA LLC (786036330)

STAT Rx USA LLC

Registrant -

PSS World Medical Inc. (101822682)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

STAT Rx USA LLC

78 6 0 36 330

relabel(16 59 0 -19 1) , repack(16 59 0 -19 1)

Revised: 8/2012

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