NDC 68788-9687 Diphenhydramine Hcl

Diphenhydramine Hcl

NDC Product Code 68788-9687

NDC CODE: 68788-9687

Proprietary Name: Diphenhydramine Hcl 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 Hcl 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)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
PH014
Score: 1

NDC Code Structure

NDC 68788-9687-0

Package Description: 10 CAPSULE in 1 BOTTLE, PLASTIC

NDC 68788-9687-1

Package Description: 15 CAPSULE in 1 BOTTLE, PLASTIC

NDC 68788-9687-3

Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC

NDC Product Information

Diphenhydramine Hcl with NDC 68788-9687 is a a human over the counter drug product labeled by Preferred Pharmaceuticals, Inc.. The generic name of Diphenhydramine Hcl is diphenhydramine hcl. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Preferred Pharmaceuticals, Inc.

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 Hcl 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 25 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.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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: Preferred Pharmaceuticals, Inc.
Labeler Code: 68788
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: 03-27-2013 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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 Hcl 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 Capsule)

Diphenhydramine HCL 25 mgDiphenhydramine HCL 50 mg

Purpose

Antihistamine

Uses:

  • •Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. •Sneezing. •Nasal congestion. •Runny nose. •Itchy, watery eyes.

Do Not Use

  • •With any other product containing Diphenhydramine HCL, including one applied topically.

Ask A Doctor Or Pharmacist Before Use

  • If you have •Trouble urinating due to enlarged prostate gland •A breathing problem such as emphysema or chronic bronchitis •Glaucoma •If you are taking sedatives or tranquilizers

When Using This Product

  • •Avoid alcoholic drinks. •Marked drowsiness may occur. •Excitability may occur, especially in children. •Alcohol, sedatives and tranquilizers may increase drowsiness. •Be careful when driving a motor vehicle or operating machinery.

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 hours •Do not take more than 6 doses in 24 hours.Adults and children 12 years or over1 to 2 capsule                                      Children 6 to under 12 years 1 capsuleChildren under 6 yearsask a doctor

Other Information:

  • •Store at room temperature 15-30  degrees C (59-86 degrees F) •Protect from excessive moisture

* Please review the disclaimer below.