NDC 0904-2056 Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

NDC Product Code 0904-2056

NDC CODE: 0904-2056

Proprietary Name: Diphenhydramine Hydrochloride 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.

Non-Proprietary Name: Diphenhydramine Hydrochloride 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.

Product Characteristics

Color(s):
PINK (C48328 - HALF PINK AND HALF CLEAR WITH WHITE POWDER INSIDE, BANDED IN RED AROUND THE MIDDLE)
PINK (C48328 - PINK, BANDED IN RED AROUND THE MIDDLE)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
CPC;835
CPC;836
Score: 1

NDC Code Structure

  • 0904 - Major Pharmaceuticals

NDC 0904-2056-61

Package Description: 10 BLISTER PACK in 1 BOX > 10 CAPSULE in 1 BLISTER PACK

NDC Product Information

Diphenhydramine Hydrochloride with NDC 0904-2056 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Diphenhydramine Hydrochloride is diphenhydramine hydrochloride. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Otc Drug 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.

Diphenhydramine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • LACTOSE (UNII: J2B2A4N98G)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • LACTOSE (UNII: J2B2A4N98G)
  • STARCH, CORN (UNII: O8232NY3SJ)

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.

Labeler Name: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 01-02-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

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Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* Please review the disclaimer below.

Diphenhydramine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Banded Capsule)

Diphenhydramine HCl… 25 mgDiphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

  • 25 MGTemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitchy throat and noseTemporarily relieves these symptoms due to the common cold:runny nosesneezing50 MGTemporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common coldsneezingrunny noseitchy, watery eyesitchy throat and nose

Warnings

  • Do not use 25 MGto make a child sleepywith any other product containing diphenhydramine, even one used on skin50 MGto make a child sleepywith any other product containing diphenhydramine, including one applied topically

Ask A Doctor Before Use If You Have

  • 25 MGa breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to an enlarged prostate gland50 MGglaucomaa breathing problem such as emphysema or chronic bronchitisdifficulty 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

  • Marked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability 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 right away.

Directions

  • Take every 4-6 hoursDo not take more than 6 doses in 24 hours25 MG adults and children 12 years of age and over1 to 2 capsuleschildren 6 years to under 12 years of age1 capsulechildren under 6 years of agedo not use this product in children under 6 years of age50 MG adults and children 12 years of age and over1 capsulechildren 6 years to under 12 years of ageAsk a doctor, the proper dosage strength is not available in this package****Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

  • Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]Protect from moistureContains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed By

MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

* Please review the disclaimer below.