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

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

Anti-diarrheal

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

Heart alert: Taking more than directed can cause serious heart problems or death

Do not use if you have bloody or black stool

Ask a doctor before use if you have

fever
mucus in your stool
a history of liver disease

Ask doctor or pharmacist before use if you are taking antibiotics

When using this product tiredness, drowsiness or dizziness may occur.Be careful when driving or operating machinery.

Stop use and ask a doctor if

symptoms get worse
diarrhea lasts more than 2 days
you get abdominal swelling or bulging. These may be signs of a serious condition.

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
drink plenty of clear fluid to help prevent dehydration caused by diarrhea
find right dose on chart. If possible, use weight to dose; otherwise use age.
Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
TSP = teaspoonful = milliliter

adults and children 12 years and older

4 teaspoonfuls (20 mL) after the first loose stool movement; 2 teaspoonfuls (10 mL) after each subsequent loose stool; but no more than 8 teaspoonfuls (40 mL) a day

children 9-11 years (60-95 lbs)

2 teaspoonfuls (10 mL) after the first loose stool movement; 1 teaspoonfuls (5 mL) after each subsequent loose stool; but no more than 6 teaspoonfuls (30 mL) a day

children 6-8 years (48-59 lbs)

2teaspoonfuls (10 mL) after the first loose stool movement; 1 teaspoonfuls (5 mL) after each subsequent loose stool; but no more than 4 teaspoonfuls (20 mL) a day

children 2-5 years (34 to 47 lbs)

ask a doctor

children under 2 years (up to 33 lbs)

do not use

Other information
Each 20 mL contains: sodium 3.2 mg
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. 618:07 05/18

Principal Display Panel

Rx Choice

NDC 50383-618-04

See New Warnings and Directions

Loperamide Hydrochloride Oral Solution

1 mg/5 mL

Anti-Diarrheal

Controls the Symptoms of Diarrhea, including Traveler’s Diarrheal

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)
Establishment
NameAddressID/FEIOperations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(50383-618)

 
Hi-Tech Pharmacal Co., Inc.

← See all Loperamide Hydrochloride brands

Medically reviewed on Aug 10, 2018

Further information

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

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