NDC 50580-317 Imodium A-d

Loperamide Hydrochloride

NDC Product Code 50580-317

NDC CODE: 50580-317

Proprietary Name: Imodium A-d 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):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
11 MM
Imprint(s):
IMO;2;MG
Score: 2

NDC Code Structure

NDC 50580-317-01

Package Description: 1 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 50580-317-03

Package Description: 4 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 50580-317-05

Package Description: 8 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC 50580-317-06

Package Description: 2 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Imodium A-d with NDC 50580-317 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The generic name of Imodium A-d is loperamide hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division

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.

Imodium A-d 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)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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: Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
Labeler Code: 50580
FDA Application Number: ANDA075232 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: 07-13-2015 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’.

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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]

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Imodium A-d Product Label Images

Imodium A-d 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

Active Ingredient (In Each Caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Allergy Alert

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Heart Alert

Taking more than directed can cause serious heart problems or death

Otc - Do Not Use

Do not use if you have bloody or black stool

Otc - Ask Doctor

  • Ask a doctor before use if you havefevermucus in the stoola history of liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking antibiotics

Otc - When Using

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Otc - Stop Use

  • Stop use and ask a doctor ifsymptoms get worsediarrhea lasts for more than 2 daysyou get abdominal swelling or bulging. These may be signs of a serious condition.

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

Directions

  • Drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. If possible, use weight to dose; otherwise, use age.adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hourschildren 9-11 years (60-95 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hourschildren 6-8 years (48-59 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hourschildren 2-5 years (34 to 47 lbs)ask a doctorchildren under 2 years (up to 33 lbs)do not use

Other Information

  • Store at 20°-25°C (68°-77°F)do not use if blister unit is broken or torn

Inactive Ingredients

Anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

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