LOPERAMIDE HYDROCHLORIDE - loperamide hydrochloride solution 
Hi-Tech Pharmacal Co., Inc.

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Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

Antidiarrheal

Uses

• controls the symptoms of diarrhea, including Traveler's Diarrhea

Warnings

Alergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use if you have bloody or black stool

Ask a doctor before use if you have

• high fever (greater than 101°F)
• mucus present in your stool
• a history of liver disease

Ask doctor or pharmacist before use if you are taking antibiotics

Stop use and ask a doctor if diarrhea lasts for more than 2 days

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.

Directions

• use enclosed dosage cup to accurately measure dosage as noted below
• drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
• find right dose on chart. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and older	4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a day
children 9-11 years (60-95 lbs)	2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a day
children 6-8 years (48-59 lbs)	2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a day
children under 6 years (up to 47 lbs)	ask a doctor (not intended for use in children under 6 years old)

Other information

• avoid excess heat
• store at room temperature, 15° - 30°C (59° - 86°F)

Inactive ingredients

alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH

Questions or comments?

Call 1-800-262-9010

Mon. - Thurs. 9:00 am - 4:30 pm EST,

Fri. 9:00 am - 2:30 pm EST

Serious side effects associated with use of this product may be reported to this number.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 618:04 11/08

Principal Display Panel

Container Label

Carton

LOPERAMIDE HYDROCHLORIDE  loperamide hydrochloride   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50383-618 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 1 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   ANHYDROUS CITRIC ACID   BENZOIC ACID   CHERRY   GLYCERIN   MINT   PROPYLENE GLYCOL   SODIUM BENZOATE   SORBITOL   SUCROSE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-618-04 1 BOTTLE In 1 CARTON contains a BOTTLE 1 118 mL In 1 BOTTLE This package is contained within the CARTON (50383-618-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074352	11/17/1995

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 10/2009Hi-Tech Pharmacal Co., Inc.