ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated 
Redpharm Drug Inc

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Major Pharmaceuticals Anti-Diarrheal Drug Facts

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 or pharmacist 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

  1. symptoms get worse
  2. diarrhea lasts for more than 2 days
  3. 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 (1-800-222-1222).

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 to 47 lbs)

ask a doctor

children under 2 years

(up to 33 lbs)

do not use

Other information

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal Controls the Symptoms of Diarrhea

Actual Size

12 CAPLETS*

*Capsule-Shaped Tablets

COMPARE TO active ingredient of IMODIUM ® A-D

anti diarrheal image
ANTI DIARRHEAL 
loperamide hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1472(NDC:0904-7725)
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorgreenScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code L2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67296-1472-724 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523202/24/2003
Labeler - Redpharm Drug Inc (828374897)
Establishment
NameAddressID/FEIBusiness Operations
Redpharm Drug Inc.828374897repack(67296-1472)

Revised: 2/2023
Document Id: f4c2cf1a-b261-f7d3-e053-2a95a90af6dc
Set id: f4c23673-056e-7608-e053-2995a90a9276
Version: 1
Effective Time: 20230215
 
Redpharm Drug Inc