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Imodium A-D: Package Insert / Prescribing Info

Package insert / product label
Generic name: loperamide hydrochloride
Dosage form: capsule, liquid filled
Drug class: Antidiarrheals

Medically reviewed by Drugs.com. Last updated on Nov 15, 2024.

Drug Facts

Active ingredient (in each capsule)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Indications and Usage for Imodium A-D

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
  • in children under 12 years of age

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

  • symptoms get worse
  • diarrhea lasts for 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 right away.

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
  • in children under 12 years of age

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

  • symptoms get worse
  • diarrhea lasts for 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 right away.

Imodium A-D Dosage and Administration

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • not for use in children under 12 years of age
  • adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Storage and Handling

  • store at 20°-25°C (68°-77°F). Protect from light.
  • avoid excessive heat above 40°C (104°F)
  • do not use if blister unit is torn or broken

Inactive ingredients

butylated hydroxyanisole, edible ink, FD&C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-367-02

Imodium ®

A-D


Loperamide HCl, 2mg/Anti-Diarrheal

Soft Gelatin Capsules

Anti-Diarrheal
Softgels

Controls the symptoms
of diarrhea

Suitable for adults and

children 12 years and over

24 Softgels*

Actual Size

*each liquid-filled capsule contains 2 mg loperamide HCl

imodium-01

IMODIUM A-D
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-367
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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
Product Characteristics
Colorblue (Light blue) Scoreno score
ShapeOVALSize12mm
FlavorImprint CodeIMO
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-367-011 in 1 CARTON07/11/2016
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-367-022 in 1 CARTON07/11/2016
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185507/11/2016
Labeler - Kenvue Brands LLC (118772437)

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