NDC 15127-338 Loperamide Hydrochloride

Product Information

Loperamide Hydrochloride is product labeled by Select Brand. The product's dosage form is and is administered via form.

Product Code15127-338
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
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Select Brand
Labeler Code15127
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.
02-01-1993
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.
12-31-2019
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".
I
NDC Code Structure

What are the uses for Loperamide Hydrochloride?


Product Characteristics

Color(s)GREEN (C48329)
ShapeCAPSULE (C48336)
Size(s)9 MM
Imprint(s)123
Score2

Product Packages

NDC 15127-338-12

Package Description: 12 TABLET in 1 BLISTER PACK

Price per Unit: $0.12043 per EA

NDC 15127-338-66

Package Description: 6 TABLET in 1 BLISTER PACK

Price per Unit: $0.12043 per EA

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Loperamide Hydrochloride 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.
  • LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C)
  • LOPERAMIDE (UNII: 6X9OC3H4II) (Active Moiety)

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:

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)
  • TRISTEARIN (UNII: P6OCJ2551R)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

* Please review the disclaimer below.

Patient Education

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.

Loperamide Hydrochloride Labeling and Warnings

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.

Table of Contents



Active Ingredient (In Each Caplet)



Loperamide HCI USP, 2 mg


Purpose



Anti-diarrheal


Uses



Controls symptoms of diarrhea, including Travelers’ Diarrhea


Warnings



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


Do Not Use



If you have bloody or black stool


Ask A Doctor Before Use If You Have



  • fever
  • mucus in the 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



  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • you get abdominal swelling or bulging. These may be signs of a serious condition.

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.


Directions



  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find 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 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 under 6 years
    (up to 47 lbs)
    ask a doctor

Other Information



  • store between 20° – 25° C (68° – 77° F)
  • see side panel for lot number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients



Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch


Questions?



Call 1800-406-7984


Principal Display Panel



select brand®

NDC 15127-338-12

Loperamide Hydrochloride Tablets USP, 2 mg

ANTI-DIARRHEAL

Controls The Symptoms Of Diarrhea

٭Compare to the active ingredient of Imodium®A-D

12 Caplets*

Each Caplet (*capsule-shaped tablet) contains Loperamide HCl USP, 2 mg

5048836/R1109


* Please review the disclaimer below.