Chlorphen mal pseudoeph hcl solution/ drops
Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Dropsis an antihistaminic and decongestant drop for oral administration.
Each dropperful (1 mL) contains:
Chlorpheniramine Maleate, USP .............. 0.8 mg
Pseudoephedrine HCl, USP ........................ 9 mg
Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Red #40, Cherry Flavor, Purified Water.
Chlorpheniramine maleate is an antihistamine having the chemical name, 2-[p-Chloro--[2-(dimethylamino)ethyl]benzyl]pyridine maleate(1:1).
Pseudoephedrine hydrochloride is a decongestant having the chemical name, (Benzenemethanol, -[1-(methylamino)ethyl]-,[S-(R*,R*)]-,hydrochloride).
Chlorpheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines compete with histamine for receptor sites on effector cells. Chlorpheniramine also has mild anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue.
Chlorpheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration reached in 2 to 6 hours in adults. 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 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. The serum half-life in adults 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
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.
This product is 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.
At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed the recommended dosage.
Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.
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, ischemic heart disease, hyperthyroidism, increased intraocular pressure, renal impairment, and prostatic hypertrophy.
Because Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Dropscontains 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, Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Dropsshould 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. Patients sensitive to antihistamines may experience moderate to severe drowsiness. In mild cases, or in particularly sensitive patients, less frequent doses may be adequate.
Do not use this medication in a child who is taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs used for depression, psychiatric or emotional conditions, or Parkinsons disease), or for 2 weeks after stopping the MAO inhibitor drug. MAO inhibitor drugs prolong and intensify the anticholinergic effects of antihistamines. (MAO) inhibitor drugs may enhance the effect of pseudoephedrine HCl.
Sympathomimetic agents may reduce the effects of antihypertensive drugs. The effects of sympathomimetic amines, such a pseudoephedrine, are increased by beta-adrenergic blockers.
Antihistamines have additive effects with alcohol and other CNS (Central Nervous System) depressants such as hypnotics, sedatives, tranquilizers, and anti-anxiety agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed to assess the carcinogenic and mutagenic potential of Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Dropsor its effect on fertility.
Pregnancy,Teratogenic Effects Pregnancy Category C
Animal reproductive studies have not been performed with Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Drops. It is also not known if it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Dropsshould be given to a pregnant woman only if clearly needed.
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Chlorphen Mal/Pseudoeph HCl 0.8/9 mg Dropsare contraindicated in nursing mothers.
The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing this drug to the elderly.
Other adverse reactions may include:
Dermatologicurticaria, drug rash, photosensitivity, pruritus.
Cardiovascular Systemhypotension, hypertension, cardiac arrhythmias, palpitations, increased heart rate or blood pressure.
Central Nervous System (CNS)disturbed coordination, tremor, irritability, excitability, insomnia, visual disturbances such as diplopia, weakness, nervousness, hallucination, pallor, convulsion, headache, euphoria, and dysphoria.
G.U. Systemurinary frequency, difficult urination.
G.I. Systemepigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory Systemtightness of chest and wheezing, shortness of breath.
Hematologic Systemhemolytic anemia, thrombocytopenia, agranulocytosis.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Signs and Symptoms
Acute overdosage with antihistamines results primarily in central nervous system effects. In the small child, predominant symptoms are excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases.
Acute overdosage with sympathomimetics include central nervous system effects such as restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent hypotension and circulatory collapse.
Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea and abdominal cramps.
In the event of overdose, induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Gastric lavage may be carried out. Precautions against aspiration must be taken, especially in infants and small children.
For CNS hyperactivity or convulsive seizures, intravenous short-acting 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
(4 times a day)
(4 times a day)
(4 times a day)
Do not exceed 4 doses during a 24-hour period.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
NDC No.: 68032-457-01 1 fl oz (30 mL) bottles
WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature].
Tamper Evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container as defined in the USP.
Rivers Edge Pharmaceuticals LLC.
Suwanee, GA 30024
Rev. 10/09 457-10
Ingredients and appearance - Product information
Chlorphen mal pseudoeph hcl solution/ drops- Chlorpheniramine maleate, pseudoephedrine hydrochloride
|Product Type||HUMAN PRESCRIPTION DRUG LABEL||Item Code (Source)||NDC: 68032-457|
|Route of Administration||Oral|
|Chlorpheniramine maleate ( UNII: V1Q0O9OJ9Z)( Chlorpheniramine - UNII: 3U6IO1965U )||.8 mgin 1 mL|
|Pseudoephedrine hydrochloride ( UNII: 6V9V2RYJ8N)( Pseudoephedrine - UNII: 7CUC9DDI9F )||9 mgin 1 mL|
|Glycerin||( UNII: PDC6A3C0OX)|
|Propylene glycol||( UNII: 6DC9Q167V3)|
|Sorbitol||( UNII: 506T60A25R)|
|Citric acid monohydrate||( UNII: 2968PHW8QP)|
|Sodium citrate||( UNII: 1Q73Q2JULR)|
|Saccharin sodium||( UNII: SB8ZUX40TY)|
|Fd&c red no. 40||( UNII: WZB9127XOA)|
|Water||( UNII: 059QF0KO0R)|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|unapproved drug other||USA|