ANTI-DIARRHEAL LOPERAMIDE HCL, 2 MG CAPLETS- loperamide hcl tablet 
SDA Laboratories, Inc.

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SDA LABORATORIES - ANTI-DIARRHEAL LOPERAMIDE HYDROCHLORIDE, 2 mg CAPLETS

Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Traveler's Diarrhea

Warnings

Allergy 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 the stool  • a history of liver disease

Ask a 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)ask a doctor

Other information

Inactive ingredients

Corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions?

call toll free 1-800-687-0176

Mon - Fri 8 am to 4 pm

Compare to the active ingredient in Imodium® A-D†

ORIGINAL PRESCRIPTION STRENGTH

CONTROLS SYMPTOMS OF DIARRHEA

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

†This product is not manufactured or distributed by the owner of the registered trademark of Imodium® A-D.

L.Rev. 08/18

Distributed by:

SDA Laboratories, Inc.

Greenwich, CT 06830

01b LBL_Anti-Diarrheal_96ct_PDP

01b LBL_Anti-Diarrheal_200ct_PDP

01b LBL_Anti-Diarrheal_96ct_DF1

01b LBL_Anti-Diarrheal_96ct_DF2

ANTI-DIARRHEAL LOPERAMIDE HCL, 2 MG CAPLETS 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-735
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorgreenScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66424-735-02200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2018
2NDC:66424-735-9696 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649709/01/2018
Labeler - SDA Laboratories, Inc. (948067889)

Revised: 4/2021
Document Id: c120d500-c1b6-708b-e053-2995a90af570
Set id: e3d4f789-d41c-4965-975b-5af743d7b8e3
Version: 4
Effective Time: 20210429
 
SDA Laboratories, Inc.