Polmon

Dexchlorpheniramine Maleate

Capellon Pharmaceuticals, Llc
Human Prescription Drug
NDC 64543-600

Polmon also known as Dexchlorpheniramine Maleate is a human prescription drug labeled by 'Capellon Pharmaceuticals, Llc'. National Drug Code (NDC) number for Polmon is 64543-600. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Polmon drug includes Dexchlorpheniramine Maleate - 2 mg/5mL . The currest status of Polmon drug is Active.

Drug Information:

Drug NDC:	64543-600
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:	Polmon
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:	Dexchlorpheniramine Maleate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Capellon Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
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:	DEXCHLORPHENIRAMINE MALEATE - 2 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:	16 Jul, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Jan, 2026
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:	ANDA202520
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:	31 Dec, 2023
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:	Capellon Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2183907
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.
UNII:	B10YD955QW
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
64543-600-04	118 mL in 1 BOTTLE (64543-600-04)	16 Jul, 2018	N/A	No
64543-600-16	473 mL in 1 BOTTLE (64543-600-16)	16 Jul, 2018	N/A	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.

Other medicines with the same generic name

Ryclora

Dexchlorpheniramine Maleate

Liquid
CARWIN PHARMACEUTICAL ASSOCIATES, LLC
NDC: 15370-150

Polmon

Dexchlorpheniramine Maleate

Solution
Capellon Pharmaceuticals, LLC
NDC: 64543-600

Product Elements:

Polmon dexchlorpheniramine maleate anhydrous citric acid fd&c red no. 40 glycerin menthol methylparaben propylparaben propylene glycol water trisodium citrate dihydrate sucrose dexchlorpheniramine maleate dexchlorpheniramine

Drug Interactions:

Drug interaction: mao inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Indications and Usage:

Indications and usage perennial and seasonal allergic rhinitis vasomotor rhinitis allergic conjunctivitis due to inhalant allergens and foods mild, uncomplicated allergic skin manifestations of urticaria and angioedema amelioration of allergic reactions to blood or plasma dermographism as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.

Warnings:

Warnings antihistamines should be used with considerable caution in patients with: narrow angle glaucoma stenosing peptic ulcer pyloroduodenal obstruction symptomatic prostatic hypertrophy bladder neck obstruction use in children: in infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. as in adults, antihistamines may diminish mental alertness in children. in the young child, particularly, they may produce excitation. use in pregnancy: experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus. use with cns depressants: polmon oral solution has additive effects with alcohol and other cns depressants (hypnotics, sedatives, tranquilizers, etc.). use in activities requiring mental alertness: patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc. use in the elderly ( Read more...

approximately 60 years or older): antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

Dosage and Administration:

Dosage and administration dosage should be individualized according to the needs and the response of the patient. recommended dosage adults and children 12 years of age and older: 2 mg (1 teaspoonful) children 6 to 11 years: 1 mg (1/2 teaspoonful) children 2 to 5 years: 0.5 mg (1/4 teaspoonful) doses are generally given every 4 to 6 hours.

Contraindications:

Contraindications use in newborn or premature infants this drug should not be used in newborn or premature infants. use in nursing mothers because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. use in lower respiratory disease antihistamines should not be used to treat lower respiratory tract symptoms including asthma. antihistamines are also contraindicated in the following conditions: hypersensitivity to dexchlorpheniramine maleate or other antihistamines of similar chemical structure monoamine oxidase inhibitor therapy (see drug interaction section)

Adverse Reactions:

Adverse reactions general: urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and the throat. cardiovascular system: hemolytic anemia, thrombocytopenia, agranulocytosis. hematologic system: hemolytic anemia, thrombocytopenia, agranulocytosis. nervous system: sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. g.i. system: epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. g.u. system: urinary frequency, difficult urination, urinary retention, early menses. respiratory system: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Drug Interactions:

Drug interaction: mao inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Overdosage:

Overdosage antihistamine overdosage reactions may vary from central nervous system depression to stimulation. stimulation is particularly likely in children. atropine-like signs and symptomsâdry mouth, fixed, dilated pupils, flushing, and gastrointestinal symptoms may also occur. if vomiting has not occurred spontaneously the patient should be induced to vomit. this is best done by having the patient drink a glass of water or milk after which the patient should be made to gag. precautions against aspiration must be taken, especially in infants and children. saline cathartics , such as milk of magnesia, draw water into the bowel by osmosis and therefore, are valuable for their action in rapid dilution of bowel content. stimulants should not be used. vasopressors may be used to treat hypotension.

Description:

Description each 5 ml (teaspoonful) contains: dexchlorpheniramine maleate, usp ............. 2 mg dexchlorpheniramine maleate, usp, an antihistamine agent, is a white, odorless crystalline powder that is freely soluble in water. the molecular formula is c 16 h 19 cln 2 â¢ c 4 h 4 o 4 , designated chemically as (+)-2-[p-chloro-Î±-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1). m.w. = 390.86 dexchlorpheniramine maleate

Clinical Pharmacology:

Clinical pharmacology dexchlorpheniramine maleate is an antihistamine with anticholinergic (drying) and sedative side effects. antihistamines appear to compete with histamine for cell receptor sites on effector cells.

How Supplied:

How supplied polmon oral solution is supplied as a red colored, cherry flavored liquid in the following sizes: 4 fl oz (118 ml), ndc 64543-600-04 16 fl oz (473 ml), ndc 64543-600-16 storage and handling store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container as defined in the usp, with child-resistant closure. rx only manufactured for: capellon pharmaceuticals, llc fort worth, tx 76118 500403-01 rev. 04/2015 capellon logo

Package Label Principal Display Panel:

Principal display panel-4 fl oz. bottle 4 fl oz. bottle label ndc 64543-600-04 polmon (dexchlorpheniramine maleate oral solution, usp) 2 mg per 5 ml rx only 4 fl oz. (118 ml) usual dosage: see package insert for complete dosage recommendations. dispense in a tight, light-resistant container with a child-resistant closure. warning: keep this and all medications out of the reach of children. store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. tamper evident by foil seal under cap. do not use if inner foil seal is broken or missing. manufactured for: capellon pharmaceuticals, llc fort worth, tx 76118 16 fl oz. bottle label ndc 64543-600-16 polmon (dexchlorpheniramine maleate oral solution, usp) 2 mg per 5 ml rx only 16 fl oz. (473 ml) usual dosage: see package insert for complete dosage recommendations. dispense in a tight, light-resistant container with a child-resistant closure. warning: keep this and all medications out of the reach of children. store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. tamper evident by foil seal under cap. do not use if inner foil seal is broken or missing. manufactured for: capellon pharmaceuticals, llc fort worth, tx 76118 4 oz. label 16 oz. label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.