Loperamide hydrochloride and Simethicone

Drug Facts

Loperamide HCl, USP 2 mg
Simethicone, USP 125 mg

Anti-diarrheal

Anti-gas

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

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

Label information

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Label information

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

Label information

If pregnant or breast-feeding, ask a health professional before use.

Label information

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)

• 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

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

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

call toll-free 1-888-235-2466

Label information

^***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

*** 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

[Image in the official label — see DailyMed source]