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NDC 70000-0417-01 leader anti diarrheal 1 mg/7.5mL Details

leader anti diarrheal 1 mg/7.5mL

leader anti diarrheal is a ORAL SOLUTION 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: 70000-0417-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	70000-0417
Product ID	70000-0417_a947c813-d7d7-4a60-8ace-2a10d0832d60
Associated GPIs	47100020100902
GCN Sequence Number	059430
GCN Sequence Number Description	loperamide HCl LIQUID 1MG/7.5ML ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	25065
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	SOLUTION
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	mg/7.5mL
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	ANDA091292
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0417-01 (70000041701)

Pricing Information
NDC Package Code	70000-0417-1
Billing NDC	70000041701
Package	120 mL in 1 BOTTLE (70000-0417-1)
Marketing Start Date	2018-07-16
NDC Exclude Flag	N
Price Per Unit	0.02667
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	ANTI-DIARRHEAL 1 MG/7.5 ML SOL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
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 c27e6fbd-8822-4784-9d24-497ae78e54f4 Details

Active ingredient (in each 7.5 mL)

Loperamide HCl 1 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.
•: shake well before using
•: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
•: mL = milliliter

adults and children 12 years and over	30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
children 9-11 years (60-95 lbs)	15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
children 6-8 years (48-59 lbs)	15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 30 mL contains: sodium 15 mg
•: store between 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Anti-Diarrheal

Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL

Anti-Diarrheal

Mint Flavor

COMPARE TO IMODIUM® A-D active ingredient

Controls the Symptoms of Diarrhea

100% Money Back Guarantee

Anti-Diarrheal Oral Solution

SEE NEW WARNING AND DIRECTIONS

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

LEADER ANTI DIARRHEAL

loperamide hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0417
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	1 mg in 7.5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	GREEN (opaque, viscous)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0417-1	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091292	07/16/2018

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

Revised: 6/2021

Document Id: a947c813-d7d7-4a60-8ace-2a10d0832d60

Set id: c27e6fbd-8822-4784-9d24-497ae78e54f4

Version: 3

Effective Time: 20210617