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Loperamide Hydrochloride by Hi-Tech Pharmacal Co., Inc.

Medically reviewed on Jul 18, 2018

Dosage form: solution
Ingredients: LOPERAMIDE HYDROCHLORIDE 1mg in 5mL
Labeler: Hi-Tech Pharmacal Co., Inc.
NDC Code: 50383-618

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

Principal Display Panel

NDC 50383-618-04

Loperamide Hydrochloride Oral Solution

1 mg/5 mL

Anti-Diarrheal

Controls the Symptoms of Diarrhea, including Travelers' Diarrhea

Each teaspoonful (5 mL) contains:

Loperamide Hydrochloride 1 mg

Contains Alcohol 0.5%

Convenient dosage cup enclosed.

4 fl oz (118 mL)

CHERRY MINT FLAVOR

 

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:50383-618-041 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:50383-618-064 TRAY in 1 CASE
210 CUP, UNIT-DOSE in 1 TRAY
2NDC:50383-618-055 mL in 1 CUP, UNIT-DOSE
3NDC:50383-618-114 TRAY in 1 CASE
310 CUP, UNIT-DOSE in 1 TRAY
3NDC:50383-618-1010 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07435211/17/1995
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

 
Hi-Tech Pharmacal Co., Inc.

← See all Loperamide Hydrochloride brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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