NDC 47682-166 Medique At Home Diphen

Diphenhydramine Hcl

NDC Product Code 47682-166

NDC CODE: 47682-166

Proprietary Name: Medique At Home Diphen 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):
11 MM
Imprint(s):
048;D
Score: 1

NDC Code Structure

  • 47682 - Unifirst First Aid Corporation

NDC 47682-166-50

Package Description: 50 PACKET in 1 BOX > 1 TABLET, FILM COATED in 1 PACKET

NDC Product Information

Medique At Home Diphen with NDC 47682-166 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medique At Home Diphen is diphenhydramine hcl. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Medique At Home Diphen 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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Unifirst First Aid Corporation
Labeler Code: 47682
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: 02-01-2021 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: 12-31-2022 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.

Medique At Home Diphen Product Label Images

Medique At Home Diphen 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each caplet)Diphenhydramine Hydrochloride 25 mg

Otc - Purpose

PurposeAntihistamine

Indications & Usage

Uses■ temporarily relieves these symptoms due to hay fever or other respiratory allergies■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes■ temporarily relieves these symptoms due to the common cold■ runny nose ■ sneezing

Warnings

Warnings

Otc - Do Not Use

Do not use■ to make a child sleepy■ with any other product containing diphenhydramine, even one that is used on skin.

Otc - Ask Doctor

Ask a doctor before use if you have■ a breathing problem such as emphysema or chronic bronchitis■ trouble urinating due to an enlarged prostate gland■ glaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Dosage & Administration

Directions■ take every 4 to 6 hours, or as directed by a doctor■ do not take more than 6 times in 24 hoursAdults and children12 years and over 1 to 2 caplets
Children 6 to under 12 years 1 caplet
Children under 6 years do not use

Other Safety Information

Other information■ store at room temperature 68º-77ºF (20º-25ºC)■ protect from light■
TAMPER EVIDENT child resistant packets
■ do not use any opened or torn packets

Inactive Ingredient

Inactive ingredientscroscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Otc - Questions

Questions or comments? 1-800-634-7680

* Please review the disclaimer below.