NDC 71594-701 Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine
Diphenhydramine Hcl Bar, Chewable Oral

Product Information

What is NDC 71594-701?

The NDC code 71594-701 is assigned by the FDA to the product Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine which is a human over the counter drug product labeled by Uspharma Ltd. The generic name of Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine is diphenhydramine hcl. The product's dosage form is bar, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 71594-701-03 10 bar, chewable in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code71594-701
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Diphenhydramine Hcl
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Diphenhydramine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
NDC Directory StatusACTIVE PRODUCT and included in NDC Directory
Dosage FormBar, Chewable - A solid dosage form usually in the form of a rectangle that is meant to be chewed.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Uspharma Ltd
Labeler Code71594
FDA Application Number What is the FDA Application Number?
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.		part341
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-02-2022
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine?


Product Characteristics

Color(s)PINK (C48328 - LIGHT PINK TO RED PINK)
ShapeRECTANGLE (C48347)
Size(s)23 MM
Imprint(s)O
Score1
Flavor(s)BUBBLE GUM (C73368)

Product Packages

NDC Code 71594-701-03

Package Description: 10 BAR, CHEWABLE in 1 BOTTLE, PLASTIC

Product Details

What are Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.

Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine Active Ingredients UNII Codes

  • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
  • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)

Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Firstcare Allergy Relief Diphenhydramine Hci, 25 Mg Antihistamine Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (In Each Piece)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


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



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. 


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


Inactive Ingredients:



citric acid, FD&C red #40, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.


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


* Please review the disclaimer below.