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NDC 70000-0225-02 Leader Anti Diarrheal 2 mg/1 Details

Leader Anti Diarrheal 2 mg/1

Leader Anti Diarrheal is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0225-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	70000-0225
Product ID	70000-0225_b6dc4239-25d5-46bf-a14d-3ed2df60dbf1
Associated GPIs	47100020100305
GCN Sequence Number	013672
GCN Sequence Number Description	loperamide HCl TABLET 2 MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	08550
HICL Sequence Number	001236
HICL Sequence Number Description	LOPERAMIDE HCL
Brand/Generic	Generic
Proprietary Name	Leader Anti Diarrheal
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loperamide HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	LOPERAMIDE HYDROCHLORIDE
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075232
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0225-02 (70000022502)

Pricing Information
NDC Package Code	70000-0225-2
Billing NDC	70000022502
Package	12 BLISTER PACK in 1 CARTON (70000-0225-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2020-02-02
NDC Exclude Flag	N
Price Per Unit	0.16931
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ANTI-DIARRHEAL 2 MG CAPLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 9079a59b-a158-4e77-a104-547959f7ba78 Details

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

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 HCl

Heart alert: Taking more than directed can cause serious heart problems or death

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
•: 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.

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; 1/2 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; 1/2 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

•: store at 20°-25°C (68°-77°F)
•: see end panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal

Controls the Symptoms of Diarrhea

COMPARE TO IMODIUM® A-D

active ingredient

12 CAPLETS*

*Capsule-Shaped Tablets

Actual Size

100% Money Back Guarantee

SEE NEW WARNINGS

DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN

INGREDIENTS AND APPEARANCE

LEADER ANTI DIARRHEAL

loperamide hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0225
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0225-1	24 in 1 CARTON	01/17/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0225-2	12 in 1 CARTON	02/02/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075232	01/17/2017

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 6/2021

Document Id: b6dc4239-25d5-46bf-a14d-3ed2df60dbf1

Set id: 9079a59b-a158-4e77-a104-547959f7ba78

Version: 4

Effective Time: 20210618