Triprolidine Hydrochloride
Westminster Pharmaceuticals, Llc
Human Otc Drug
NDC 69367-253Triprolidine Hydrochloride is a human otc drug labeled by 'Westminster Pharmaceuticals, Llc'. National Drug Code (NDC) number for Triprolidine Hydrochloride is 69367-253. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Triprolidine Hydrochloride drug includes Triprolidine Hydrochloride - .938 mg/mL . The currest status of Triprolidine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 69367-253 |
| 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: | Triprolidine Hydrochloride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Triprolidine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Westminster Pharmaceuticals, Llc |
| 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: | TRIPROLIDINE HYDROCHLORIDE - .938 mg/mL
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 09 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Dec, 2025 |
| 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: | part341 |
| 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: | Westminster Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1491649
|
| 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: | YAN7R5L890
|
| 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 |
|---|
| 69367-253-30 | 1 BOTTLE, DROPPER in 1 CARTON (69367-253-30) / 30 mL in 1 BOTTLE, DROPPER | 09 Mar, 2020 | 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. |
Purpose:
Purpose antihistamine
Product Elements:
Triprolidine hydrochloride triprolidine hydrochloride triprolidine hydrochloride triprolidine citric acid monohydrate glycerin methylparaben ammonium glycyrrhizate potassium citrate potassium sorbate propylene glycol propylparaben water sucralose
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes
Warnings:
Warnings do not exceed recommended dosage. ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland ask a doctor before use if you are taking sedatives or tranquilizers when using this product may cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
When Using:
When using this product may cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not exceed recommended dosage. use only the enclosed dropper. do not use enclosed dropper for any other drug product. age dose adults & children 12 years of age or older: 2.67 ml (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 ml (10 milligrams) in 24 hours, or as directed by a doctor. children 6 to under 12 years of age: 1.33 ml (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 ml (5 milligrams) in 24 hours, or as directed by a doctor. children under 6 years of age: consult a doctor.
Stop Use:
Stop use and ask a doctor if new symptoms occur
Package Label Principal Display Panel:
Principal display panel - 30 ml bottle carton ndc 69367-253-30 triprolidine hcl antihistamine each dropperful (1 ml) contains: triprolidine hcl 0.938 mg sugar-free ⢠dye free alcohol free tamper evident by foil seal under cap. do no use if foil seal is broken or missing. bubble gum flavor 1 fl oz (30 ml) westminster pharmaceuticals principal display panel - 30 ml bottle carton
Further Questions:
Questions? comments? call 1-844-221-7294.