LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride solution 
Preferred Pharmaceuticals, Inc.

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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
Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

Loperamide Hydrochloride Oral Solution 1mg/5ml

Rx Choice

NDC 68788-9773

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

Relabeled By: Preferred Pharmaceuticals Inc.

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9773(NDC:50383-618)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE1 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CHERRY (UNII: BUC5I9595W)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINT (UNII: FV98Z8GITP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9773-11 in 1 CARTON07/27/201208/01/2021
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07435207/27/201208/01/2021
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9773)

Revised: 1/2023
 
Preferred Pharmaceuticals, Inc.