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NDC 00363-1010-53 anti diarrheal 2 mg/1 Details

anti diarrheal 2 mg/1

anti diarrheal is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-1010-53
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loperamide

Product Information

NDC	00363-1010
Product ID	0363-1010_6609d6be-959d-4bea-9e54-2e19f459c5fa
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	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	Walgreen Company
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 00363-1010-53 (00363101053)

Pricing Information	N/A
NDC Package Code	0363-1010-53
Billing NDC	00363101053
Package	12 BLISTER PACK in 1 CARTON (0363-1010-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2021-09-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6e0dfbb3-6c58-40fc-83b4-09ee10576ae5 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

Walgreens

WALGREENS PHARMACIST RECOMMENDED

Compare to the active ingredient in Imodium® A-D

Anti-Diarrheal

LOPERAMIDE HYDROCHLORIDE TABLETS, 2 mg

ANTI-DIARRHEAL

• Controls the symptoms of diarrhea

12 CAPLETS*

(*capsule-shaped tablets)

ACTUAL SIZE

SEE NEW WARNINGS

INGREDIENTS AND APPEARANCE

ANTI DIARRHEAL

loperamide hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-1010
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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:0363-1010-53	12 in 1 CARTON	09/11/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0363-1010-62	24 in 1 CARTON	09/14/2021
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0363-1010-91	6 in 1 CARTON	09/14/2021
3		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	09/11/2021

Labeler - Walgreen Company (008965063)

Revised: 5/2022

Document Id: 6609d6be-959d-4bea-9e54-2e19f459c5fa

Set id: 6e0dfbb3-6c58-40fc-83b4-09ee10576ae5

Version: 3

Effective Time: 20220511