ANTI-DIARRHEAL- loperamide hydrochloride tablet 
Advanced Rx LLC

----------

ANTI-DIARRHEAL

Loperamide Hydrochloride Caplets, 2 mg

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

Controls symptoms of diarrhea, including Travelers' 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
  • a history of abnormal heart rhythm

Ask a doctor before use if you are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 (1-800-222-1222) right away.

Directions

adults and children 12 years and over

2 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 2-5 years (34-47 lbs)ask a doctor
children under 2 years (up to 33 lbs)do not use

Other information

Inactive ingredients

corn starch, D&C yellow#10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel.

Questions?

call toll-free 1-800-630-8895

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St,

North Miami Beach,

FL 33162 U.S.A.

Principal Display Panel

NDC 80513-401-24

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

Anti-Diarrheal

Loperamide Hydrocholoride Caplets, 2 mg

Controls Symptoms of Diarrhea

Easy To Swallow

24 CAPLETS

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

label

ANTI-DIARRHEAL 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-401
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 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
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:80513-401-244 in 1 CARTON08/11/2024
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649701/01/2024
Labeler - Advanced Rx LLC (042795108)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464manufacture(80513-401) , label(80513-401) , pack(80513-401)

Revised: 8/2024
Document Id: 1f6363e2-256d-68c3-e063-6394a90ac6c1
Set id: 287bd6d9-aa29-4f56-9c7f-5cbacbf62537
Version: 1
Effective Time: 20240811
 
Advanced Rx LLC