Loperamide Oral Solution

Name: Loperamide Oral Solution

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.

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).

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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:0054-8534-16 5 mL in 1 CUP, UNIT-DOSE
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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:0054-8535-16 10 mL in 1 CUP, UNIT-DOSE
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: 10/2009   Roxane Laboratories, Inc

Loperamide Side Effects

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • bloated, swollen feeling in your abdomen
  • blurred vision
  • loss of appetite
  • signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat palpitations; feeling faint or lightheaded, falls; breathing problems
  • stomach pain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

constipation

  • drowsiness or dizziness
  • dry mouth
  • nausea, vomiting

Loperamide May Interact with Other Medications

Do not take this medicine with any of the following medications:

alosetron

This medicine may also interact with the following medications:

  • cimetidine
  • clarithromycin
  • erythromycin
  • gemfibrozil
  • itraconazole
  • ketoconazole
  • quinidine
  • quinine
  • ranitidine
  • ritonavir
  • saquinavir
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
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