Anti-Diarrheal

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

if you have bloody or black stool.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• a 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product,

OTC - WHEN USING SECTION

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• find right dose on chart. If possible, use weight to dose; otherwise, use age.

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

STORAGE AND HANDLING SECTION

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store between 20º-25ºC (68º-77ºF)
• see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
IMODIUM® A-D*

ANTI-
DIARRHEAL

• Loperamide HCl Tablets, 2 mg
Anti-diarrheal

Controls the symptoms of diarrhea

Actual Size

12 caplets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR
SHOWS ANY SIGNS OF TAMPERING

1. To open, tear
at perforations and
remove a section.

2. Use ✄ to cut
through plastic
for caplet.

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Imodium® A-D.
50844      REV0619L37502

ITEM# 10682

Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

• Anti-Diarrheal
• Loperamide HCl
• LOPERAMIDE HYDROCHLORIDE
• LOPERAMIDE
• STARCH, CORN
• D&C YELLOW NO. 10 ALUMINUM LAKE
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• FD&C BLUE NO. 1 ALUMINUM LAKE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• SILICON DIOXIDE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

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Inactive ingredient links page 1 of 3 · 145 matching rows.

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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