Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine
Diphenhydramine Hcl
Uspharma Ltd
Human Otc Drug
NDC 71594-701Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine also known as Diphenhydramine Hcl is a human otc drug labeled by 'Uspharma Ltd'. National Drug Code (NDC) number for Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine is 71594-701. This drug is available in dosage form of Bar, Chewable. The names of the active, medicinal ingredients in Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine drug includes Diphenhydramine Hydrochloride - 25 mg/1 . The currest status of Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine drug is Active.
Drug Information:
| Drug NDC: | 71594-701 |
| 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: | Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine |
| 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: | Diphenhydramine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Uspharma Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Bar, Chewable |
| 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 25 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: | 02 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | USpharma Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | TC2D6JAD40
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [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 |
|---|
| 71594-701-03 | 10 BAR, CHEWABLE in 1 BOTTLE, PLASTIC (71594-701-03) | 02 Mar, 2022 | 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:
Firstcare allergy relief diphenhydramine hci, 25 mg antihistamine diphenhydramine hcl anhydrous citric acid fd&c red no. 40 corn syrup hydroxypropyl betadex magnesium stearate maltitol maltodextrin neotame water carrageenan sodium chloride starch, corn sucralose sucrose trisodium citrate dihydrate diphenhydramine hydrochloride diphenhydramine light pink to red pink o
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing
Warnings:
Warnings do not use to make child sleepy with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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 (1-800-222-1222) right away.
When Using:
When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hour age (yr) dose (piece) adults and children 12 years and over 1 to 2 pieces (25 mg to 50 mg) children 6 to 11 years 1 piece (25 mg) children under 6 years do not use
Package Label Principal Display Panel:
Principal display panel-25 mg bottle label firstcare ndc 71594-701-03 ***made in usa*** patent pending allergy relief diphenhydramine hci 25 mg antihistamine bubblegum flavor chewy bites relief of: ⢠sneezing, runny nose ⢠itchy, watery eyes ⢠itchy throat 10 pieces soft chews principal display panel-25 mg bottle label