LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride solution 
Atlantic Biologicals Corps

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Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

Antidiarrheal

Uses

Warnings

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Alergy alert:

if you have bloody or black stool Do not use

Ask a doctor before use if you have

taking antibiotics Ask doctor or pharmacist before use if you are

diarrhea lasts for more than 2 days Stop use and ask a doctor if

, ask a health professional before use If pregnant or breast-feeding

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

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

LOPERAMIDE HYDROCHLORIDE SOLUTION

Label Image
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0618(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:17856-0618-110 mL in 1 CUP; Type 0: Not a Combination Product10/16/2019
2NDC:17856-0618-55 mL in 1 CUP; Type 0: Not a Combination Product10/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07435211/17/1995
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-0618) , REPACK(17856-0618)

Revised: 10/2019
Document Id: 5a00eb66-d425-467c-a2d8-6e82a701348b
Set id: b0596b9c-326d-4795-b0a5-38c858af7a77
Version: 5
Effective Time: 20191016
 
Atlantic Biologicals Corps