J-TAN D PD
-
brompheniramine maleate and
pseudoephedrine hydrochloride liquid
JayMac Pharmaceuticals LLC
----------
J-TAN D PD DropsJ-Tan D PD Drops
NDC 64661-032-30Rx Only
DESCRIPTION
J-Tan D PD is an antihistaminic drop for oral administration containing the following amounts of
active ingredients in each 1 mL dropperful:
Brompheniramine Maleate, USP............... 1 mg
Pseudoephedrine HCl............................ 7.5 mg
Inactive ingredients: Glycerin, Sorbitol, Propylene Glycol, Citric Acid, Sodium Citrate, Sodium Saccharin,
Cotton Candy Flavor, Purified Water.
Brompheniramine maleate is an antihistamine having the chemical name, 2-pyridinepropanamine,
γ-(4-bromophenyl)-N, N-dimethyl-, (±)-, (Z)-2-butenedioate (1:1), with the following chemical structure:
Pseudoephedrine Hydrochloride is a nasal decongestant with the chemical name Benzenemethanol,
α-[1-(methylamino)ethyl]-, [S-(R*,R*)-, hydrochloride. Its structure is as follows:
CLINICAL PHARMACOLOGY
Antihistaminic and decongestant actions.Brompheniramine Maleate
Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging
to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor
sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the
antihistaminic effects, it antagonizes the allergic response (vasodilatation, increased vascular permeability,
increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal
tract, with peak plasma concentration after a single, oral dose of 4 mg reached in 5 hours; urinary excretion
is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main
site of metabolic transformation.
Pseudoephedrine Hydrochloride
Pseudoephedrine hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory
tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine
has less pressor effect in normotensive adults. Serum half-life for pseudoephedrine is 6 to 8 hours. Acidic
urine is associated with faster elimination of the drug. About one-half of the administered dose is excreted in
the urine.
INDICATIONS AND USAGE
J-Tan D PD Drops is indicated for symptomatic relief of upper respiratory symptoms, including nasalcongestion, associated with allergy or the common cold.
CONTRAINDICATIONS
Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Do not use in newborn infants,premature infants, in nursing mothers, in patients with severe hypertension, severe coronary artery
disease, ischemic heart disease, or in those receiving monoamine oxidase (MAO) inhibitors.
Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic
ulcer, and during an asthma attack. Antihistamines should not be used to treat lower respiratory tract
conditions including asthma.
WARNINGS
Antihistamines may diminish mental alertness, and may cause hyperexcitability especially in children.At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur.
Especially in infants and small children, antihistamines in overdosage may cause hallucinations,
convulsions, and death. Use with caution in patients with hypertension, ischemic heart disease, and
persons older than 60 years old. Do not give this product to children who have a chronic pulmonary
disease, breathing problems such as chronic bronchitis, glaucoma, or those who are taking sedatives
or tranquilizers without first consulting with a doctor. Considerable caution should be exercised in
patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased
intraocular pressure and prostatic hypertrophy.
Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occurs,
discontinue use and consult a doctor.
PRECAUTIONS
GeneralBecause J-Tan D PD Drops contain an antihistamine, it should be used with caution in patients with
a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder
neck obstruction. Due to its sympathomimetic component, J-Tan D PD Drops should be used with
caution in patients with diabetes, hypertension, heart disease, or thyroid disease.
Information for Patients (or Parents)
Patients (or parents) should be warned about engaging in activities requiring mental alertness. In mild
cases or in particularly sensitive patients, less frequent doses may be adequate.
Drug Interactions:
Do not use this medication in a child who is 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. MAO inhibitors prolong and intensify the anticholinergic effects of
antihistmaines and may enhance the effect of pseudoephedrine HCl. Sympathomimetic agents may
reduce the effects of anti-hypertensive drugs. Antihistamines have additive effects with alcohol and
other CNS (Central Nervous System) depressants (hypnotics, sedatives, tranquilizers, anti-anxiety
agents, etc.).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed to assess the carcinogenic and mutagenic potential of J-Tan D PD
Drops or its effect on fertility.
Pregnancy, Teratogenic Effects - Pregnancy Category C
Animal reproductive studies have not been performed with J-Tan D PD Drops. It is also not known if it
can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
J-Tan D PD Drops should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns
and prematures in particular, J-Tan D PD Drops is contraindicated in nursing mothers.
Geriatric Use
The elderly (60 years of age or older) are more likely to experience adverse reactions. Caution should
be taken when prescribing this drug to the elderly.
ADVERSE REACTIONS
The most frequent adverse reactions to J-Tan D PD Drops include: sedation; dryness of mouth, nose,and throat; thickening of bronchial secretions; dizziness.
Other adverse reactions may include:
Dermatologic - urticaria, drug rash, photosensitivity, pruritis.
Cardiovascular System - hypotension, hypertension, cardiac arrhythmias, palpitations.
Central Nervous System (CNS) - disturbed coordination, tremor, irritability, insomnia, visual
disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria.
G.U. System - urinary frequency, difficult urination.
G.I. System - epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory System - tightness of chest and wheezing, shortness of breath.
Hematologic System- hemolytic anemia, thrombocytopenia, agranulocytosis.
OVERDOSAGE
Signs and SymptomsCentral nervous system effects from overdosage of brompheniramine may vary from depression
to stimulation, especially in children.
Anticholinergic effects may also occur.
Overdosage of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension and
cardiac arrhythmias; signs of CNS depression may occasionally be seen.
Treatment
Include emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions
against aspiration must be taken, especially in infants and small children. Gastric lavage may
be carried out, but in some cases tracheotomy may be needed prior to lavage. For CNS
hyperactivity or convulsive seizures, intravenous shortacting barbiturates may be indicated.
Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous
fluids and other supportive measures should be used as indicated.
DOSAGE AND ADMINISTRATION:
Take by mouth only.| AGE | DOSE* | FREQUENCY |
| Children 6 to 12 years of age | 2 dropperfuls (2.0 mL) | 4 times a day |
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
HOW SUPPLIED
J-Tan D PD Drops is a cotton candy-flavored, sugar-free, alcohol-free, dye-free liquid packagedin 30 mL bottles for dropper dosage, NDC 64661-032-30. Calibrated, shatterproof dropper
enclosed in each carton.
STORAGE
Store at 20o-25oC (68o-77oF). Dispense in a tight, light-resistant container as defined in the USP/NFwith a child-resistant cap. Dispense in the original container. Avoid exposure to excessive heat.
Keep tightly closed.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR
CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Rx Only
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
Manufactured for:
JayMac Pharmaceuticals
Sunset, LA 70584
Rev. 01/08
PRODUCT PACKAGING:
The packaging below represents the labeling used:Principal Display Panel and Side Panel for 30 mL Label:
NDC 64661-032-30
J-TAN D PD
Drops
Each dropperful (1 mL) contains:
Brompheniramine Maleate........ 1 mg
Pseudoephedrine HCl.............. 7.5 mg
ANTIHISTAMINE / DECONGESTANT
SUGAR FREE / ALCOHOL FREE
DYE FREE
COTTON CANDY FLAVOR
Rx Only
1 fl oz (30 mL)
DOSAGE* AND ADMINISTRATION:
FOR ORAL USE ONLY
Children 6 to under 12 years of age - 2 dropperfuls (2.0 mL).
Dosages may be repeated every 4-6 hours if required for relief. Not to exceed 4 doses
in 24 hours.
*Titrate dosage individually.
Refer to package insert for complete prescribing information.
STORAGE: Store between 20o-25oC (68o-77oF). Avoid exposure to excessive heat.
Keep tightly closed.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE
OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
Manufactured for:
JayMac Pharmaceuticals
Sunset, LA 70584
Rev. 01/08
| J-TAN
D PD
brompheniramine maleate and pseudoephedrine hydrochloride liquid |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 06/05/2007 | |
| Labeler - JayMac Pharmaceuticals LLC (830767260) |
| Registrant - Great Southern Laboratories (056139553) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Great Southern Laboratories | 056139553 | manufacture | |