NDC 55319-481 Allergy Relief

Diphenhydramine Hcl

NDC Product Code 55319-481

NDC CODE: 55319-481

Proprietary Name: Allergy Relief 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):
WHITE (C48325)
PINK (C48328)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
CPC835;P25
Score: 1

NDC Code Structure

  • 55319 - Family Dollar (family Wellness)

NDC 55319-481-01

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 100 CAPSULE in 1 BOTTLE, PLASTIC

NDC Product Information

Allergy Relief with NDC 55319-481 is a a human over the counter drug product labeled by Family Dollar (family Wellness). The generic name of Allergy Relief is diphenhydramine hcl. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Family Dollar (family Wellness)

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.

Allergy Relief 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.

  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • LACTOSE (UNII: J2B2A4N98G)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • 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: Family Dollar (family Wellness)
Labeler Code: 55319
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: 06-30-2016 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.

Allergy Relief Product Label Images

Allergy Relief 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 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergiessneezing
  • Runny nose
  • Itchy, watery eyes
  • Itching of the nose or throat

Do Not Use

  • To make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • Glaucomatrouble urinating due to an enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

Taking sedatives or tranquilizers.

When Using This Product

  • Marked drowsiness may occuravoid alcoholic drinks
  • Alcohol, sedatives, and tranquilizers may increase drowsinessbe 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 right away.

Directions

  • Take every 4 to 6 hours do not take more than 6 doses in 24 hoursadults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsulechildren under 6 years of age do not use

Other Information

  • Store between 15-30ºC (59° to 86°F)
  • Protect from light

Inactive Ingredients

Butylparaben*, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, FD&C yellow #6*, gelatin, lactose*, lactose monohydrate*, magnesium stearate*, methylparaben*, polysorbate 80*, propylparaben*, purified water*, sodium lauryl sulphate*, starch*contains one or more of these ingredients

Product Label

Family Wellness Allergy Relief

* Please review the disclaimer below.