NDC 62207-739 Loperamide Hydrochloride And Simethicone
Tablet Oral

Product Information

What is NDC 62207-739?

The NDC code 62207-739 is assigned by the FDA to the product Loperamide Hydrochloride And Simethicone which is a human over the counter drug product labeled by Granules India Ltd. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 62207-739-69 2 blister pack in 1 carton / 6 tablet in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code62207-739
Proprietary Name 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.		Loperamide Hydrochloride And Simethicone
Non-Proprietary Name 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.		Loperamide Hydrochloride And Simethicone
Product Type 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.		Human Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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.		Granules India Ltd
Labeler Code62207
FDA Application Number 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.		ANDA215981
Marketing Category 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.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-01-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Loperamide Hydrochloride And Simethicone?


Product Characteristics

Color(s)WHITE (C48325 - OFF WHITE)
ShapeCAPSULE (C48336)
Size(s)17 MM
Imprint(s)I;9
Score2
Flavor(s)VANILLA (C73421)

Product Packages

NDC Code 62207-739-69

Package Description: 2 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

Product Details

What are Loperamide Hydrochloride And Simethicone Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DIMETHICONE 125 mg/1
  • LOPERAMIDE HYDROCHLORIDE 2 mg/1 - One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.

Loperamide Hydrochloride And Simethicone Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 978001 - loperamide HCl 2 MG / simethicone 125 MG Oral Tablet
  • RxCUI: 978001 - loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet

Loperamide Hydrochloride And Simethicone Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Loperamide Hydrochloride And Simethicone Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts


Active Ingredients (In Each Caplet)



Loperamide HCl, 2 mg

Simethicone, 125 mg


Purposes



Anti-diarrheal
Anti-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 HCl

Heart alert

Taking more than directed can cause serious heart problems or death



Do Not Use



  • if you have bloody or black stool
  • if you have difficulty swallowing

Ask A Doctor Before Use If You Have



  • fever
  • mucus in the stool
  • a history of liver disease
  • a 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 worse
  • diarrhea lasts for more than 2 days
  • you 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 diarrhea
  • take only on an empty stomach (1 hour before or 2 hours after a meal)
  • take with a full (8 oz.) glass of water
  • find right dose on chart below. If possible, use weight to dose; otherwise, use ag
    • 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 hours
    children 9-11 years (60-95 lbs)1 caplet after the first loose stool;

    ½ caplet after each subsequent loose stool; but no more than 3

    caplets in 24 hours
    children 6-8 years (48-59 lbs)1 caplet after the first loose stool;

    ½ caplet after each subsequent loose stool; but no more than 2

    caplets in 24 hours
    children 2-5 years (34 to 47 lbs)ask a doctor
    children under 2 years (up to 33 lbs)do not use

    Other information

    • each caplet contains: calcium 148.40 mg, sodium 1.40 mg
    • store between 20-25°C (68-77°F). Protect from light.
    • for blister: do not use if blister unit is torn or broken

Inactive Ingredients



acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid.



Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Manufactured by:

Granules India Limited

Hyderabad-500 081, INDIA


MADE IN INDIA


Principal Display Panel



Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg


ANTI-DIARRHEAL / ANTI-GAS

Multi-Symptom Relief Caplet

Relieves symptoms of diarrhea plus

* Please review the disclaimer below.