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NDC 69452-0210-04 Loperamide hydrochloride and Simethicone 125; 2 mg/1; mg/1 Details

Loperamide hydrochloride and Simethicone 125; 2 mg/1; mg/1

Loperamide hydrochloride and Simethicone is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is DIMETHICONE; 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: 69452-0210-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 69452-0210-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	69452-0210
Product ID	69452-210_ceb56ab8-4a61-6dee-e053-2995a90aab30
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 and Simethicone
Proprietary Name Suffix	n/a
Non-Proprietary Name	loperamide hydrochloride and simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	125; 2
Active Ingredient Units	mg/1; mg/1
Substance Name	DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Labeler Name	Bionpharma Inc.
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213484
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69452-0210-04 (69452021004)

Pricing Information	N/A
NDC Package Code	69452-210-04
Billing NDC	69452021004
Package	1 BLISTER PACK in 1 CARTON (69452-210-04) / 6 TABLET in 1 BLISTER PACK
Marketing Start Date	2021-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9b0a802f-6fae-4142-ad2f-4b16ed67400e Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each caplet)

Loperamide HCl, USP 2 mg

Simethicone, USP 125 mg

Purposes

Anti-diarrheal

Anti-gas

Uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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
if you have difficulty swallowing

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.
you have difficulty swallowing the caplet

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
take only on an empty stomach (1 hour before or 2 hours after a meal)
take with a full (8 oz.) glass of water
find right dose on chart below. 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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 2 years to 5 years (34 lbsto 47 lbs)	ask a doctor
children under 2 years (up to 33 lbs)	do not use

Other information

each caplet contains: calcium 155 mg, sodium 3 mg
store between 20° to 25°C (68° to 77°F). Protect from light.

Inactive ingredients

acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

Questions or comments?

call toll-free 1-888-235-2466

***All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® Multi-Symptom Relief

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured for:

BIONPHARMA

600 Alexander Road,

Princeton, NJ 08540

MADE IN INDIA

Rev # 09/19

L0000000

PRINCIPAL DISPLAY PANEL

*** Compare to the active ingredients in Imodium ® Multi-Symptom Relief

NDC 69452-210-04

Loperamide HCl

and Simethicone Tablets,

2 mg/125 mg

Antidiarrheal/Anti-gas

Multi-Symptom Relief

Caplet

Relieves symptoms of diarrhea plus

Cramps & Pressure
Bloating
Gas

Actual Size

6 Caplets*

*Capsule-shaped Tablets

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

loperamide hydrochloride and simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69452-210
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
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
VANILLA (UNII: Q74T35078H)

Product Characteristics
Color	white (off-white)	Score	2 pieces
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	LS1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69452-210-04	1 in 1 CARTON	12/19/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:69452-210-12	4 in 1 CARTON	12/19/2021
2		6 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	ANDA213484	12/01/2021

Labeler - Bionpharma Inc. (079637826)

Registrant - Bionpharma Inc. (079637826)

Name	Address	ID/FEI	Business Operations
Establishment
Recipharm Pharmaservices Pvt. Ltd.		871401927	manufacture(69452-210)

Revised: 10/2021

Document Id: ceb56ab8-4a61-6dee-e053-2995a90aab30

Set id: 9b0a802f-6fae-4142-ad2f-4b16ed67400e

Version: 2

Effective Time: 20211019