LOPERAMIDE HYDROCHLORIDE tablet

Loperamide Hydrochloride by

Drug Labeling and Warnings

Loperamide Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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; 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

SPL UNCLASSIFIED SECTION

Keep the carton. It contains important information.

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

R0319

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.

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-123
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	green	Score	2 pieces
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51660-123-06	1 in 1 CARTON	02/01/1993
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51660-123-12	2 in 1 CARTON	02/01/1993
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 51660-123-24	4 in 1 CARTON	02/01/1993
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074091	02/01/1993

Labeler - Ohm Laboratories Inc. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(51660-123)