Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide
Lannett Company, Inc.
Human Prescription Drug
NDC 0527-5302Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide also known as Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide is a human prescription drug labeled by 'Lannett Company, Inc.'. National Drug Code (NDC) number for Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide is 0527-5302. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide drug includes Brompheniramine Maleate - 2 mg/5mL Dextromethorphan Hydrobromide - 10 mg/5mL Pseudoephedrine Hydrochloride - 30 mg/5mL . The currest status of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide drug is Active.
Drug Information:
| Drug NDC: | 0527-5302 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Brompheniramine Maleate, Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lannett Company, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Syrup |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | BROMPHENIRAMINE MALEATE - 2 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE - 30 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 17 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA213125 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 17 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Lannett Company, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1357010
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0305275302645
|
| UPC stands for Universal Product Code. |
| UNII: | IXA7C9ZN03
9D2RTI9KYH
6V9V2RYJ8N
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Adrenergic alpha-Agonists [MoA]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0527-5302-64 | 118 mL in 1 BOTTLE, PLASTIC (0527-5302-64) | 17 Apr, 2020 | 31 Dec, 2023 | No |
| 0527-5302-70 | 473 mL in 1 BOTTLE, PLASTIC (0527-5302-70) | 17 Apr, 2020 | 31 Aug, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide brompheniramine maleate brompheniramine pseudoephedrine hydrochloride pseudoephedrine dextromethorphan hydrobromide dextromethorphan alcohol anhydrous citric acid fd&c red no. 40 glycerin methylparaben propylene glycol sodium benzoate sucrose trisodium citrate dihydrate water light pink
Indications and Usage:
Indications and usage for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Warnings:
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.
Dosage and Administration:
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.
Contraindications:
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.
Adverse Reactions:
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:
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 13â17 mg/kg. another 2½-year-old child survived a dose of 300â900 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 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.
Description:
Description brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, light pink syrup with a grape 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: alcohol, anhydrous citric acid, fd&c red no. 40, glycerin, methylparaben, propylene glycol, sodium benzoate, sucrose, trisodium citrate dihydrate, water and artificial grape flavor. 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. c 16 h 19 brn 2 â¢c 4 h 4 o 4 m.w. 435.31 brompheniramine maleate , usp (±)- 2 - p - bromo - α - 2 -( dimethylamino ) ethylbenzylpyridine maleate ( 1 : 1 ) c 10 h 15 noâ¢hcl m.w. 201.69 pseudoephedrine hydrochloride , usp (+)- pseudoephedrine hydrochloride c 18 h 25 noâ¢hbrâ¢h 2 o 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. bromfed-01 bromfed-02 bromfed-03
Clinical Pharmacology:
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 Î
Read more...-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.
How Supplied:
How supplied brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, light pink-colored, grape-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 0527-5302-64 16 fl oz (473 ml) ndc 0527-5302-70
Package Label Principal Display Panel:
Principal display panel bottle label ndc 0527- 5302 -64 brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup 2 mg, 30 mg, 10 mg/5 ml alcohol 0.95% v/v rx only 4 fl oz (118 ml) lannett label