LOPERAMIDE HYDROCHLORIDE solution

Loperamide Hydrochloride by

Drug Labeling and Warnings

Loperamide Hydrochloride by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

HOW SUPPLIED

Product: 50090-0461

NDC: 50090-0461-0 118 mL in a BOTTLE / 1 in a CARTON

Loperamide Hydrochloride

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-0461(NDC:50383-618)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-0461-0	1 in 1 CARTON	11/28/2014
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074352	11/17/1995

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0461)