NDC 0924-0036 Physicianscare Allergy Antihistamine

Diphenhydramine Hydrochloride

NDC Product Code 0924-0036

NDC Code: 0924-0036

Proprietary Name: Physicianscare Allergy Antihistamine 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 - PINK)
Shape: OVAL (C48345)
Size(s):
11 MM
Imprint(s):
048;D
061;T
Score: 1

NDC Code Structure

  • 0924 - Acme United Corporation

NDC 0924-0036-01

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

NDC Product Information

Physicianscare Allergy Antihistamine with NDC 0924-0036 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicianscare Allergy Antihistamine is diphenhydramine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Acme United 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.

Physicianscare Allergy Antihistamine 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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)

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: Acme United Corporation
Labeler Code: 0924
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: 11-01-2017 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: 12-31-2020 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.

Physicianscare Allergy Antihistamine Product Label Images

Physicianscare Allergy Antihistamine 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

Otc - Active Ingredient

Active Ingredients (in each tablet)Diphenhydramine Hydochloride 25 mg

Otc - Purpose

Purpose
Antihistamine

Indications & Usage

  • Uses
  • Temporarily relieves these symptoms due to hay fever or other respiratory allergies
  • Runny nosesneezingitching nose or throatitchy-watery eyestemporarily relieves these symptoms due to the common coldrunny nosesneezing

Warnings

  • WarningsDo Not Useto make a child sleepywith any other product containing diphenhydramine, even one that is used on the skin.Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitisdifficuly in urination due to enlargement of the prostate glandglaucomaAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizersWhen using this product
  • * marked drowsiness may occur and avoid alcoholic beverages
  • * alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • * use caution when driving a motor vehicle or operating machinery
  • * excitability may occur, especially in children
  • If pregnant or breast feeding, ask a health professionalbefore use

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.In case of overdose, contact a physician or poison control center immediately.

Dosage & Administration

DirectionsDo not use more than directedAdults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.

Information For Patients

  • Other information each caplet may contain: calium 25mgstore at room temperature 59°-86°F (15°-30°C)protect from lightuse by expiration date on packettamper-evident sealed packetsdo not use any opened or torn packets

Inactive Ingredient

Inactive ingredients
carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

*may contain.

Otc - Questions

Questions?1-800-835-2263

* Please review the disclaimer below.