DRUGS & SUPPLEMENTS
What is the dose of the medication you are taking?
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see Drug Interactions).
Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.
Because of its antihistamine component, Penbrosol Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Penbrosol (Brompheniramine Maleate) Cough Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.
Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.
Monoamine oxidase inhibitors-Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Penbrosol (Brompheniramine Maleate) Cough Syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS).
Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).
Sympathomimetic may reduce the effects of antihypertensive drugs.
Animal studies of Penbrosol Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.
Animal reproduction studies have not been conducted with Penbrosol Cough Syrup. It is also not known whether Penbrosol (Brompheniramine Maleate) Cough Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Reproduction studies of Penbrosol (Brompheniramine Maleate) maleate (a component of Penbrosol (Brompheniramine Maleate) Cough Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Penbrosol (Brompheniramine Maleate) Cough Syrup is contraindicated in nursing mothers.
Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).
The most frequent adverse reactions to Penbrosol (Brompheniramine Maleate) Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:
Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation.CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, 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.
Central nervous system effects from overdosage of Penbrosol may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.
Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of Penbrosol (Brompheniramine Maleate). The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.
Induce 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, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, 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 employed as indicated.
Adults and pediatric patients 12 years of age and over: 2 teaspoonfuls every 4 hours. Children 6 to under 12 years: 1 teaspoonful every 4 hours. Children 2 to under 6 years of age: ½ teaspoonful every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.
Penbrosol Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) Penbrosol (Brompheniramine Maleate) maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following size:
1 Pint (473 mL)
Store at 20 ° to 25 °C (68 ° to 77 °F).
KEEP TIGHTLY CLOSEDDispense in a tight, light-resistant container as defined in the USP.
Product No.: 8482Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053A50-8482-16
Indication: For the treatment of nasal congestion, control of urinary incontinence, priapism and obesity.
Penbrosol (Phenylpropanolamine Hydrochloride) (PPA), a sympathomimetic agent structurally similar to pseudoephedrine, is used to treat nasal congestion. Penbrosol (Phenylpropanolamine Hydrochloride) is found in appetite suppressant formulations and with guaifenesinin in cough-cold formulations. In 2000, the FDA requested that all drug companies discontinue marketing products containing Penbrosol (Phenylpropanolamine Hydrochloride), due to an increased risk of hemorrhagic stroke in women who used Penbrosol (Phenylpropanolamine Hydrochloride).
Depending on the reaction of the Penbrosol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Penbrosol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Penbrosol addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology