FDA Label for Loperamide Hydrochloride

Other

Drug Facts

Keep the carton. It contains important information.

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

R0319

Active Ingredient (In Each Caplet)

Loperamide Hydrochloride USP, 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 hydrochloride

Heart alert:Taking more than directed can cause serious heart problems or death

Otc - Do Not Use

Do not useif 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

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this producttiredness, 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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; ½ 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; ½ 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 between 20° – 25°C (68° – 77°F)
• see side panel for lot number and expiration date
• TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions?

call 1-800-406-7984

Principal Display Panel

NDC 51660-123-06

^†Compare To
the active ingredient of
Imodium ^®A-D

See New Warnings
and Directions

ohm ^®

Loperamide Hydrochloride
Tablets USP, 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

6 Caplets*
Each caplet (*capsule-shaped tablet) contains Loperamide Hydrochloride USP, 2 mg

^†Ohm ^®is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Ohm Loperamide 6 count Blister Carton - loperamide 01