Ed-a-hist Pse
Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride
Edwards Pharmaceuticals, Inc.
Human Otc Drug
NDC 0485-0210Ed-a-hist Pse also known as Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride is a human otc drug labeled by 'Edwards Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Ed-a-hist Pse is 0485-0210. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Ed-a-hist Pse drug includes Pseudoephedrine Hydrochloride - 60 mg/1 Triprolidine Hydrochloride - 2.5 mg/1 . The currest status of Ed-a-hist Pse drug is Active.
Drug Information:
| Drug NDC: | 0485-0210 |
| 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: | Ed-a-hist Pse |
| 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: | Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Edwards Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| 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: | PSEUDOEPHEDRINE HYDROCHLORIDE - 60 mg/1
TRIPROLIDINE HYDROCHLORIDE - 2.5 mg/1
|
| 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: | 08 Oct, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 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: | 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: | EDWARDS PHARMACEUTICALS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1099446
|
| 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: | 3004850210012
|
| UPC stands for Universal Product Code. |
| UNII: | 6V9V2RYJ8N
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. |
| Pharmacologic Class: | Adrenergic alpha-Agonists [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 |
|---|
| 0485-0210-01 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01) | 08 Oct, 2011 | 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:
Active ingredients (in each tablet) purpose pseudoephedrine hci 60 mg nasal decongestant triprolidine hci 2.5 mg. antihistamine
Product Elements:
Ed-a-hist pse pseudoephedrine hydrochloride and triprolidine hydrochloride fd&c blue no. 2 fd&c yellow no. 5 magnesium stearate cellulose, microcrystalline sodium starch glycolate type a corn pseudoephedrine hydrochloride pseudoephedrine triprolidine hydrochloride triprolidine ed;pse
Indications and Usage:
Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages
Warnings:
Warnings do not exceed recommended dosage. do not use this product if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if nerv
Read more...ousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever new symptoms occur if pregnant or breast-feeding, ask a health professional before use, keep out of reach of children. in case of accidental overdose, seek professional help or contact a poison control center immediately.
Do Not Use:
Warnings do not exceed recommended dosage. do not use this product if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever new symptoms occur if pregnant or breast-feeding, ask a health professional before use, keep out of reach of children. in case of accidental overdose, seek professional help or contact a poison control center immediately.
When Using:
When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not exceed recommended dosage. adults and children 12 years of age and over: 1 tablet every 4-6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 1/2 tablet every 4-6 hours, not to exceed 2 tablets 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 nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever new symptoms occur
Package Label Principal Display Panel:
Principal display panel - 100 tablet bottle label ndc 00485-0210-01 ed a-hist pse tablets nasal decongestant ⢠antihistamine each tablet contains: pseudoephedrine hci 60 mg triprolidine hci 2.5 mg this bottle is not to be dispensed to consumer. dispense in a tight, light-resistant container with a child-resistant cap. store at 59°-86°f (15°-30°c) (see usp controlled room temperature]. tamper evident by foil seal under cap. do not use if foil seal is broken or missing. manufactured for: edwards pharmaceuticals, inc . ripley, ms 38663 100 tablets principal display panel - 100 tablet bottle label
Further Questions:
Questions or comments? call 1-800-543-9560 rev. 11/11