ANTIDIARRHEAL RELIEF- loperamide hcl tablet 
Honeywell Safety Products USA, Inc

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0498-1071: Antidiarrheal

Active ingredient (in each caplet)

Loperamide HCl USP 2 mg

Purpose

Antidiarrheal

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 attack: 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 doctorif

  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • you get abdominal swelling or bulging.

These may be signsor 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.

Do not use if individual packet is torn or open.

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 (60-95Ibs) 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(48-59lbs) 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

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions?

call 1-800-430-5490

MM1

Antidiarrheal 100 count

Antidiarrheal Label

Antidiarrheal

ANTIDIARRHEAL RELIEF 
loperamide hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1071
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
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 68401960MK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
CORN OIL (UNII: 8470G57WFM)  
Product Characteristics
Colorgreen (Bright Green) Score2 pieces
ShapeCAPSULESize10mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-1071-07100 in 1 CARTON11/07/2018
1NDC:0498-1071-001 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409104/29/2013
Labeler - Honeywell Safety Products USA, Inc (118768815)
Registrant - Honeywell Safety Products USA, Inc (118768815)
Establishment
NameAddressID/FEIBusiness Operations
OHM LABORATORIES INC.184769029manufacture(0498-1071)

Revised: 1/2024
Document Id: 0f500a24-750b-2de1-e063-6294a90ad59f
Set id: 98fdf3b6-f883-40dd-afba-c7b241638f90
Version: 8
Effective Time: 20240119
 
Honeywell Safety Products USA, Inc