LOPERAMIDE HYDROCHLORIDE tablet

Loperamide Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH CAPLET)

Loperamide HCI 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 HCI

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

Ask a doctor or pharmacist before use if you are

Taking antibiotics

When using this product

• tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

• diarrhea lasts for more than 2 days
• symptoms get worse
• 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 under 6 years (up to 47 lbs): ask a doctor

OTHER INFORMATION

• store between 20° – 25° C (68° – 77° F)
• see side panel for lot number and expiration date
• TAMPER EVIDENT: THIS PRODUCT 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, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

QUESTIONS?

Call 1800-406-7984

PRINCIPAL DISPLAY PANEL

NDC: 55319-554-53

FAMILY wellness™

COMPARE TO THE ACTIVE INGREDIENT OF IMODIUM®A-D*

Anti-Diarrheal

Loperamide HCL Tablets USP, 2 mg

Controls the Symptoms of Diarrhea

12 CAPLETS†

Each caplet (†capsule-shaped tablet) contains Loperamide HCl USP, 2 mg

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,

5085259/R0411

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-554
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TRISTEARIN (UNII: P6OCJ2551R)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

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: 55319-554-53	12 in 1 BLISTER PACK

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

Labeler - Family Dollar Services, Inc. (024472631)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(55319-554)