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NDC 63187-0462-12 Loperamide Hydrochloride 2 mg/1 Details

Loperamide Hydrochloride 2 mg/1

Loperamide Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is LOPERAMIDE HYDROCHLORIDE.

MedlinePlus Drug Summary

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.

Related Packages: 63187-0462-12
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	63187-0462
Product ID	63187-462_4b48b484-e780-4b66-a6ca-35c5d61bcf41
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Loperamide Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loperamide Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	LOPERAMIDE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA074091
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0462-12 (63187046212)

Pricing Information	N/A
NDC Package Code	63187-462-12
Billing NDC	63187046212
Package	12 TABLET in 1 BLISTER PACK (63187-462-12)
Marketing Start Date	2014-03-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 82e65393-25b7-4114-9c71-5840ee8bad84 Details

ACTIVE INGREDIENT (IN EACH CAPLET)

Loperamide HCl USP, 2 mg

PURPOSE

Anti-diarrheal

USE(S)

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 (1-800-222-1222).

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 over	2 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

Keep the carton. It contains important information.

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

NDC 63187-462-12

Loperamide HCl Tablets, USP 2 mg

Anti-Diarrheal

12 CAPLETS†

Each caplet(†capsule-shaped tablet) contains Loperamide HCl, USP 2 mg

Controls The Symptoms of Diarrhea

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

*This product is not manufactured or distributed by McNeil-PPC, distributor of Imodium® A-D.

Imodium®is a registered trademark of Johnson & Johnson.

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE

loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-462(NDC:51660-123)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (120 .MU.M) (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)
GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	green	Score	2 pieces
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	123
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-462-12	12 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/27/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074091	02/01/1993

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-462) , RELABEL(63187-462)

Revised: 5/2022

Document Id: 4b48b484-e780-4b66-a6ca-35c5d61bcf41

Set id: 82e65393-25b7-4114-9c71-5840ee8bad84

Version: 6

Effective Time: 20220502