NDC 80136-384 Loperamide Hydrochloride And Simethicone

Loperamide Hydrochloride And Simethicone

NDC Product Code 80136-384

NDC CODE: 80136-384

Proprietary Name: Loperamide Hydrochloride And Simethicone 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 And Simethicone 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 - OFF-WHITE)
Shape: CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
T;79
Score: 2
Flavor(s):
VANILLA (C73421)

NDC Code Structure

  • 80136 - Northeast Pharma
    • 80136-384 - Loperamide Hydrochloride And Simethicone

NDC 80136-384-24

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

NDC Product Information

Loperamide Hydrochloride And Simethicone with NDC 80136-384 is a a human over the counter drug product labeled by Northeast Pharma. The generic name of Loperamide Hydrochloride And Simethicone is loperamide hydrochloride and simethicone. The product's dosage form is tablet and is administered via oral form.

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.

Loperamide Hydrochloride And Simethicone 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.


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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
  • MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Northeast Pharma
Labeler Code: 80136
FDA Application Number: ANDA211059 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: 10-27-2021 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 - 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.

Loperamide Hydrochloride And Simethicone 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

Drug Facts

Active ingredients (in each caplet) Loperamide HCl USP 2 mgSimethicone USP 125 mg

Purposes

Anti-diarrhealAnti-gas

Uses

Relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Do Not Use

  • If you have bloody or black stoolif you have difficulty swallowing

Ask A Doctor Before Use If You Have

  • Fevermucus in the stoola history of liver diseasea history of abnormal heart rhythm

Ask A Doctor Or Pharmacist Before Use If You Are

Taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 worsediarrhea lasts for more than 2 daysyou get abdominal swelling or bulging. These may be signs of a serious condition.you have difficulty swallowing the caplet

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.(1-800-222-1222)

Directions

  • Drink plenty of clear fluids to help prevent dehydration caused by diarrheatake only on an empty stomach (1 hour before or 2 hours after a meal)take with a full (8 oz.) glass of waterfind right dose on chart below. 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 to 11 years (60 to 95 lbs)1 caplet after the first loose stool; ½ capletafter each subsequent loose stool; but no more than 3 caplets in 24 hourschildren 6 to 8 years (48 to 59 lbs)1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hourschildren 2 to 5 years (34 to 47 lbs)ask a doctorchildren under 2 years (up to 33 lbs)do not use

Other Information

  • Each caplet contains: calcium 165 mg, sodium 4 mgstore between 20° to 25°C (68° to 77°F). Protect from light.do not use if carton is opened or if individual blister units are torn or opened

Inactive Ingredients

Acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate anhydrous, flavor, microcrystalline cellulose, stearic acid.

* Please review the disclaimer below.