Loperamide Oral Solution

Generic Name: loperamide hydrochloride

Dosage Form: oral solution
LOPERAMIDE HYDROCHLORIDE ORAL SOLUTION

1 mg per 5 mL

Rx only

CONSUMER INFORMATION ON USES, DIRECTIONS AND WARNINGS FOR LOPERAMIDE HYDROCHLORIDE ORAL SOLUTION. PLEASE SAVE THIS FOR FUTURE REFERENCE.

ANTIDIARRHEAL

Loperamide hydrochloride oral solution relieves diarrhea for adults and children 6 years and older, often in just one dose. Loperamide hydrochloride has been recommended for millions of people, and has been proven to be an exceptionally safe and effective antidiarrheal medication.

INDICATION

Loperamide hydrochloride oral solution controls the symptoms of diarrhea, including Travelers’ Diarrhea.

DIRECTIONS

Use the enclosed dosage cup to accurately measure loperamide hydrochloride as noted below. Drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea.

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

Take 4 teaspoonfuls (20 mL) after the first loose bowel movement and 2 teaspoonfuls (10 mL) after each subsequent loose bowel movement but no more than 8 teaspoonfuls (40 mL) a day for no more than 2 days.

CHILDREN 9-11 years old (60-95 lbs)

Take 2 teaspoonfuls (10 mL) after the first loose bowel movement and 1 teaspoonful (5 mL) after each subsequent loose bowel movement but no more than 6 teaspoonfuls (30 mL) a day for no more than 2 days.

CHILDREN 6-8 years old (48-59 lbs)

Take 2 teaspoonfuls (10 mL) after the first loose bowel movement and 1 teaspoonful (5 mL) after each subsequent loose bowel movement but no more than 4 teaspoonfuls (20 mL) a day for no more than 2 days.

Children under 6 years old (up to 47 lbs): Consult a physician. Not intended for use in children under 6 years old.

Warnings

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Do not use for more than two days unless directed by a physician. DO NOT USE IF DIARRHEA IS ACCOMPANIED BY HIGH FEVER (GREATER THAN 101°F), OR IF BLOOD OR MUCUS IS PRESENT IN THE STOOL, OR IF YOU HAVE HAD A RASH OR OTHER ALLERGIC REACTION TO LOPERAMIDE HYDROCHLORIDE. If you are taking antibiotics or have a history of liver disease, consult a physician before using this product. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Store at Room Temperature 15°-30°C (59°-86°F).

ACTIVE INGREDIENT

Loperamide Hydrochloride 1 mg per teaspoonful (5 mL). Alcohol and sugar free.

Inactive Ingredients: flavor, glycerin, methylparaben, propylene glycol, propylparaben, sodium saccharin, and water.

4055609 047

Revised April 1997

© RLI, 1997

Package Label - Loperamide Hydrochloride Oral Solution

NDC 0054-8534-16 - 1 mg/5 mL - Anitdiarrheal

Roxane Laboratories, Inc.

NDC 0054-8535-16 - 2 mg/10 mL - Anitdiarrheal

Roxane Laboratories, Inc.

LOPERAMIDE HYDROCHLORIDE  loperamide hydrochloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-8534 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength GLYCERIN   METHYLPARABEN   PROPYLENE GLYCOL   PROPYLPARABEN   SACCHARIN SODIUM   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0054-8534-16 5 mL In 1 CUP, UNIT-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073079	04/30/1992

LOPERAMIDE HYDROCHLORIDE  loperamide hydrochloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-8535 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg  in 10 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   METHYLPARABEN   PROPYLENE GLYCOL   PROPYLPARABEN   SACCHARIN SODIUM   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0054-8535-16 10 mL In 1 CUP, UNIT-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073079	04/30/1992

Labeler - Roxane Laboratories, Inc (058839929)

Registrant - Roxane Laboratories, Inc (058839929)

Establishment
Name	Address	ID/FEI	Operations
Boehringer Ingelheim Roxane Inc		128407710	MANUFACTURE

Revised: 10/2009Roxane Laboratories, Inc

More Loperamide Oral Solution resources

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• 8 Reviews for Loperamide - Add your own review/rating

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