Label: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, syrup

  • NDC Code(s): 71930-026-18, 71930-026-43
  • Packager: Eywa Pharma Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 26, 2020

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  • DESCRIPTION

    Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup, 2 mg/30 mg/10 mg per 5 mL is a clear, light pink syrup with a butterscotch flavour.


    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, alcohol, FD&C Red No. 40, glycerin, sucrose, 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 4.0 and 6.0.


    bromfed-str1


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


    bromfed-str2



    Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride 

    bromfed-str3



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

    Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.

  • CLINICAL PHARMACOLOGY

    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 (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after 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 acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α- sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.


    Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

  • INDICATIONS AND USAGE

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

  • CONTRAINDICATIONS

    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 PRECAUTIONS - Drug Interactions).


    Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

  • WARNINGS

    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.

  • PRECAUTIONS

    General

    Because of its antihistamine component, brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide 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, brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

    Information for Patients

    Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

    Drug Interactions

    Monoamine oxidase (MAO) 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 brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS).


    Central nervous system (CNS) depressants
    Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.)


    Antihypertensive drugs
    Sympathomimetic may reduce the effects of antihypertensive drugs.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Animal studies of Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

    Pregnancy

    Teratogenic Effects
    Pregnancy Category C
    Animal reproduction studies have not been conducted with brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup. It is also not known whether brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide 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 brompheniramine maleate (a component of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide 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.

    Nursing Mothers

    Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is contraindicated in nursing mothers.

    Pediatric Use

    Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).

    Geriatric Use

    Clinical studies of brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics.


    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.

  • ADVERSE REACTIONS

    The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide 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.

  • OVERDOSAGE

    Signs and Symptoms
    Central nervous system effects from overdosage of brompheniramine 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.


    Toxic Doses
    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 brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.


    Treatment
    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 shortacting 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.

  • DOSAGE AND ADMINISTRATION

    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.

  • HOW SUPPLIED

    Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:


    4 fl oz (118 mL)                             NDC 71930-026-18
    1 pint (473 mL)                              NDC 71930-026-43


    RECOMMENDED STORAGE
    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].


    KEEP TIGHTLY CLOSED


    Dispense in a tight, light-resistant container as defined in the USP


    Rx Only


    Manufactured by:
    WES Pharma Inc
    Westminster, MD – 21157
    USA


    Distributed by:
    Eywa Pharma Inc.,
    2 Research Way, Floor 3,
    Princeton, NJ 08540


    REV. 04/20

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    4 fl oz (118 mL)

     

    bromfed-label118

     

    1 pint (473 mL)

     

    bromfed-label2

  • INGREDIENTS AND APPEARANCE
    BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, 
    brompheniramine maleate, pseudoephedrine hydrochloride, syrup
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71930-026
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE (UNII: C151H8M554)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorPINK (Light Pink) Score    
    ShapeSize
    FlavorBUTTERSCOTCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71930-026-18118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    2NDC:71930-026-43473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21117006/26/2020
    Labeler - Eywa Pharma Inc (080465609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wes Pharma Inc078706898LABEL(71930-026) , MANUFACTURE(71930-026) , PACK(71930-026)