Ryclora
Dexchlorpheniramine Maleate
Carwin Pharmaceutical Associates, Llc
Human Prescription Drug
NDC 15370-150Ryclora also known as Dexchlorpheniramine Maleate is a human prescription drug labeled by 'Carwin Pharmaceutical Associates, Llc'. National Drug Code (NDC) number for Ryclora is 15370-150. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ryclora drug includes Dexchlorpheniramine Maleate - 2 mg/5mL . The currest status of Ryclora drug is Active.
Drug Information:
| Drug NDC: | 15370-150 |
| 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: | Ryclora |
| 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: | Carwin Pharmaceutical Associates, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | 07 Oct, 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: | CARWIN PHARMACEUTICAL ASSOCIATES, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2183907
2183912
|
| 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: | 0315370150164
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 15370-150-04 | 118 mL in 1 BOTTLE, PLASTIC (15370-150-04) | 07 Oct, 2018 | N/A | No |
| 15370-150-16 | 473 mL in 1 BOTTLE, PLASTIC (15370-150-16) | 07 Oct, 2018 | N/A | No |
| 15370-150-99 | 20 mL in 1 BOTTLE, PLASTIC (15370-150-99) | 07 Oct, 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. |
Product Elements:
Ryclora dexchlorpheniramine maleate dexchlorpheniramine maleate dexchlorpheniramine citric acid monohydrate fd&c red no. 40 glycerin menthol, unspecified form methylparaben propylene glycol propylparaben water trisodium citrate dihydrate sucrose
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 ryclora⢠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 elderl
Read more...y (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. call your doctor for medical advice about side effects. you may voluntarily report side effects to fda at 1-800-fda-1088. quest
Read more...ions or comments? call carwin pharmaceutical associates, llc at 1-844-700-5011.
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-α-[2-(dimethylamino)ethyl]benzyl] pyridine maleate (1:1). m.w. = 390.86 inactive ingredients: citric acid, cherry flavoring, fd&c red no. 40, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, and sugar. chemical structure
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 ryclora⢠oral solution is supplied as a red colored, cherry flavored liquid in the following sizes: 4 fl oz (118 ml), ndc 15370-150-04 16 fl oz (473 ml), ndc 15370-150-16 0.7 fl oz (20ml), ndc 15370-150-99 (as physician sample) recommended storage store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container as defined in the usp, with child-resistant closure.
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle label ndc 15370-150-16 ryclora⢠(dexchlorpheniramine maleate) oral solution, usp 2 mg/5 ml cherry flavor rx only 16 fl. oz (473 ml) carwin pharmaceutical associates principal display panel - 473 ml bottle label