NDC 47682-200 Medique Diamode

Loperamide Hydrochloride

NDC Product Code 47682-200

NDC CODE: 47682-200

Proprietary Name: Medique Diamode 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: Loperamide 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):
GREEN (C48329 - GREEN)
Shape: OVAL (C48345)
Size(s):
10 MM
Imprint(s):
123
Score: 2

NDC Code Structure

NDC 47682-200-33

Package Description: 100 PACKET in 1 BOX > 1 TABLET in 1 PACKET

NDC 47682-200-46

Package Description: 1 TABLET in 1 PACKET

NDC 47682-200-50

Package Description: 50 PACKET in 1 BOX > 1 TABLET in 1 PACKET

NDC 47682-200-64

Package Description: 24 PACKET in 1 BOX > 1 TABLET in 1 PACKET

NDC 47682-200-69

Package Description: 6 PACKET in 1 BOX > 1 TABLET in 1 PACKET

NDC Product Information

Medique Diamode with NDC 47682-200 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medique Diamode is loperamide hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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 Diamode 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.

  • LOPERAMIDE HYDROCHLORIDE 2 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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 68401960MK)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • 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: Unifirst First Aid Corporation
Labeler Code: 47682
FDA Application Number: ANDA074091 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 12-30-2008 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 - 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".

* Please review the disclaimer below.

Information for Patients

Loperamide

Loperamide is pronounced as (loe per' a mide)

Why is loperamide medication prescribed?
Nonprescription (over-the-counter) loperamide is used to control diarrhea, including travelers' diarrhea. Prescription loperamide is used to control diarrhea, including o...
[Read More]

* Please review the disclaimer below.

Medique Diamode 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

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl

Active Ingredient (In Each Caplet)

Loperamide Hydrochloride 2mg

Purpose

Antidiarrheal

Uses

Controls the symptoms of diarrhea, including Travelers diarrhea.

Do Not Use

  • If you have bloody or black stool

Ask A Doctor Before Use If You Have

  • A fever
  • Mucus in stool
  • A history of liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking antibiotics

When Using This Product

  • Tiredness, drowsiness or dizziness may occur
  • Be careful when driving or operating machinery

Stop Use And Ask A Doctor If

  • Symptoms get worse
  • Diarrhea lasts more than 2 days
  • You get abdominal swelling or bulging. These may be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or Poison Control Center right away.

Directions

  • Do not use more than directed
  • Drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Adults and children (12 years and older): Take 2 caplets after the first loose stool followed by 1 caplet after each subsequent loose stool but no more than 4 caplets in 24 hours.
  • Children under 12 years: Do not give to children under 12 years of age.

Other Information

  • Store at room temperature 59º - 86ºF (15º - 30ºC)
  • Tamper-evident sealed packets
  • Do not use any opened or torn packet

Inactive Ingredients

Anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10, FD&C Blue # 1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

* Please review the disclaimer below.