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Loperamide Hydrochloride by A-S Medication Solutions

Dosage form: solution
Ingredients: LOPERAMIDE HYDROCHLORIDE 1mg in 5mL
Labeler: A-S Medication Solutions
NDC Code: 50090-0461

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 older4 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. 618:05 4/12

HOW SUPPLIED

Product: 50090-0461

NDC: 50090-0461-0 118 mL in a BOTTLE

Loperamide Hydrochloride
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0461(NDC:50383-618)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE1 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
BENZOIC ACID 
CHERRY 
GLYCERIN 
MINT 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
WATER 
Packaging
#Item CodePackage Description
1NDC:50090-0461-01 BOTTLE in 1 CARTON
1 118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07435211/17/1995
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-0461)

Revised: 10/2017
 
A-S Medication Solutions

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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