OTC Medication Information: Anti-Diarrheal

ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

Active ingredient (in each capsule)

Loperamide HCI 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
  • 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

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 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.

Directions

  • 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 of age 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

Other information

  • store at 20°-25°C (68°-77°F). Protect from light
  • avoid excessive heat above 40°C (104°F)
  • do not use if carton or blister unit is open or torn
  • see side panel for lot number and expiration date

Inactive ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF IMODIUM® A-D*

ANTI-DIARRHEAL

LOPERAMIDE HCI SOFT GELATIN CAPSULES, 2 MG

Anti-diarrheal

Suitable for adults and children 12 years and over

Controls the symptoms of diarrhea

softgels**

**each liquid-filles capsule

contains 2 mg loperamide HCI

*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Imodium® A-D.

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Product Label

Loperamide HCI 2 mg
(click image for full-size original)

ASSURED Anti-Diarrheal

ANTI-DIARRHEAL
loperamide hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0820
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
FD&C BLUE NO. 1
GELATIN
GLYCERIN
GLYCERYL MONOCAPRYLATE
POLYOXYL 40 HYDROGENATED CASTOR OIL
WATER
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code LP2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33992-0820-2 12 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (33992-0820-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021855 09/30/2018 12/31/2023
Labeler — ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

Revised: 10/2021 ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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