LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE- loperamide hydrochloride and simethicone tablet 
Bionpharma Inc.

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Bion Loperamide Simethicone Tablets

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

adults and children 12 years and over2 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

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

Actual Size

6 Caplets*

*Capsule-shaped Tablets

6 Caplets - Carton

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
loperamide hydrochloride and simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (off-white) Score2 pieces
ShapeCAPSULESize17mm
FlavorImprint Code LS1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69452-210-041 in 1 CARTON12/19/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69452-210-124 in 1 CARTON12/19/2021
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21348412/01/2021
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Recipharm Pharmaservices Pvt. Ltd.871401927manufacture(69452-210)

Revised: 10/2021
Document Id: ceb56ab8-4a61-6dee-e053-2995a90aab30
Set id: 9b0a802f-6fae-4142-ad2f-4b16ed67400e
Version: 2
Effective Time: 20211019
 
Bionpharma Inc.