Loperamide Hydrochloride

Fred's Inc.
Ranbaxy Pharmaceuticals Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENT (IN EACH CAPLET)
• PURPOSE
• USE
• WARNINGS
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When Using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding
  • Keep out of reach of children.
• DIRECTIONS
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

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 batch 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

fred's ^®

Loperamide Hydrochloride Tablets USP, 2 mg

Anti-Diarrheal

Controls The Symptoms of Diarrhea

24 CAPLETS^*

Each Caplet (^*capsule-shaped tablet)

contains Loperamide HCl USP, 2 mg

Compare to Active Ingredient of Imodium ^® A-D ^†

DISTRIBUTED BY: fred's Inc.

5091235/R1111