Brompheniramine Maleate label

Brompheniramine Maleate

Brompheniramine Maleate Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Antihistamines may diminish mental alertness. In the young child, they may produce excitation.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

History

There is currently no drug history available for this drug.

Other Information

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup is a clear, light pink syrup with a butterscotch flavor.

Each 5 mL (1 teaspoonful) contains:

Brompheniramine Maleate, USP

2 mg

Pseudoephedrine Hydrochloride, USP

30 mg

Dextromethorphan Hydrobromide, USP

10 mg

Alcohol 0.95% v/v

In a palatable, aromatic vehicle.

Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0.

Chemical Structure

C16H19BrN2∙C4H4O4

M.W. 435.31

Brompheniramine Maleate, USP
(±)-2-p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)

Chemical Structure

C10H15NO ∙ HCl

M.W. 201.69

Pseudoephedrine Hydrochloride, USP
(+)-Pseudoephedrine hydrochloride

Chemical Structure

C18H25NO ∙ HBr ∙ H2O

M.W. 370.32

Dextromethorphan Hydrobromide, USP
3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate

Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.

Brompheniramine Maleate Manufacturers

  • Proficient Rx Lp
    Brompheniramine Maleate | Proficient Rx Lp
    No Recall

    Brompheniramine Maleate | Proficient Rx Lp

    Brompheniramine Maleate | Proficient Rx Lp

    Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours.Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

    Do not exceed 6 doses during a 24-hour period.

  • Paddock Laboratories, Llc
    Brompheniramine Maleate | Paddock Laboratories, Llc
    No Recall

    Brompheniramine Maleate | Paddock Laboratories, Llc

    Brompheniramine Maleate | Paddock Laboratories, Llc

    Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

    Do not exceed 6 doses during a 24-hour period.

  • Paddock Laboratories, Llc
    Brompheniramine Maleate | Ingenus Pharmaceuticals, Llc
    No Recall

    Brompheniramine Maleate | Ingenus Pharmaceuticals, Llc

    Brompheniramine Maleate | Ingenus Pharmaceuticals, Llc
    Hypertension

    The initial dose of atenolol is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to atenolol 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.

    Atenolol may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.

    Angina Pectoris

    The initial dose of atenolol is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to atenolol 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect.

    Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg.

    Acute Myocardial Infarction

    In patients with definite or suspected acute myocardial infarction, treatment with atenolol I.V. injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. Atenolol I.V. injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of atenolol I.V. injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately.

    In patients who tolerate the full intravenous dose (10 mg), atenolol tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, atenolol can be given orally either 100 mg once daily or 50 mg twice a day for a further 6 to 9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, atenolol should be discontinued. (See full prescribing information prior to initiating therapy with atenolol tablets.)

    Data from other beta-blocker trials suggest that if there is any question concerning the use of IV beta-blocker or clinical estimate that there is a contraindication, the IV beta-blocker may be eliminated and patients fulfilling the safety criteria may be given atenolol tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded).

    Although the demonstration of efficacy of atenolol is based entirely on data from the first seven postinfarction days, data from other beta-blocker trials suggest that treatment with beta-blockers that are effective in the postinfarction setting may be continued for one to three years if there are no contraindications.

    Atenolol is an additional treatment to standard coronary care unit therapy.

    Elderly Patients or Patients with Renal Impairment

    Atenolol is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.

    No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73 m 2. Accumulation of atenolol and prolongation of its half-life were studied in subjects with creatinine clearance between 5 and 105 mL/min. Peak plasma levels were significantly increased in subjects with creatinine clearances below 30 mL/min.

    The following maximum oral dosages are recommended for elderly, renally-impaired patients and for patients with renal impairment due to other causes:

    Creatinine Clearance
    (mL/min/1.73 m 2) Atenolol
    Elimination Half-Life
    (h) Maximum Dosage 15 to 35 16 to 27 50 mg daily < 15 > 27 25 mg daily

    Some renally-impaired or elderly patients being treated for hypertension may require a lower starting dose of atenolol: 25 mg given as one tablet a day. If this 25 mg dose is used, assessment of efficacy must be made carefully. This should include measurement of blood pressure just prior to the next dose ("trough" blood pressure) to ensure that the treatment effect is present for a full 24 hours.

    Although a similar dosage reduction may be considered for elderly and/or renally-impaired patients being treated for indications other than hypertension, data are not available for these patient populations.

    Patients on hemodialysis should be given 25 mg or 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

    Cessation of Therapy in Patients with Angina Pectoris

    If withdrawal of atenolol therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.

  • Brompheniramine Maleate | Boca Pharmacal, Llc
    No Recall

    Brompheniramine Maleate | Boca Pharmacal, Llc

    Brompheniramine Maleate | Boca Pharmacal, Llc

    Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours.  Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

    Do not exceed 6 doses during a 24-hour period.

  • Morton Grove Pharmaceuticals, Inc.
    Brompheniramine Maleate | Morton Grove Pharmaceuticals, Inc.
    No Recall

    Brompheniramine Maleate | Morton Grove Pharmaceuticals, Inc.

    Brompheniramine Maleate | Morton Grove Pharmaceuticals, Inc.

    Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours.Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

    Do not exceed 6 doses during a 24-hour period.