Loperamide Hydrochloride

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Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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. 618:05 4/12

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 68151-0618

NDC: 68151-0618-1 1 mL in a SYRINGE, PLASTIC

LOPERAMIDE HYDROCHLORIDE SOLUTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Loperamide Hydrochloride
• LOPERAMIDE
• ALCOHOL
• ANHYDROUS CITRIC ACID
• BENZOIC ACID
• CHERRY
• GLYCERIN
• MINT
• PROPYLENE GLYCOL
• SODIUM BENZOATE
• SORBITOL
• SUCROSE
• WATER

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Ingredients#

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DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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Product history page 1 of 2 · 43 observed states.

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