Loperamide Hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide Hydrochloride USP, 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride

Heart alert

SPL UNCLASSIFIED SECTION

Taking more than directed can cause serious heart problems or death

OTC - DO NOT USE SECTION

Do not useif you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever
• mucus in the stool
• a history of liver disease
• a history of abnormal heart rhythm

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

OTC - WHEN USING SECTION

When using this producttiredness, 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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; ½ 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; ½ 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

STORAGE AND HANDLING SECTION

• store between 20° – 25°C (68° – 77°F)
• see side panel for lot number and expiration date
• TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions?

OTC - QUESTIONS SECTION

Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

SPL UNCLASSIFIED SECTION

PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106

PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE
INGREDIENT IN IMODIUM ^®A-D ^†

Best
Choice ^®

See New Warnings and Directions

Anti-Diarrheal
Loperamide Hydrochloride Tablets
USP, 2 mg

Anti-Diarrheal
Controls the symptoms of diarrhea

12 CAPLETS*

EACH CAPLET (*CAPSULE-SHAPED TABLET)
CONTAINS LOPERAMIDE HYDROCHLORIDE USP, 2 mg

DailyMed RxNorm Mappings#

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Products#

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

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

• Loperamide Hydrochloride
• ANHYDROUS LACTOSE
• CROSCARMELLOSE SODIUM
• CROSPOVIDONE (15 MPA.S AT 5%)
• D&C YELLOW NO. 10
• FD&C BLUE NO. 1
• HYDROGENATED COTTONSEED OIL
• MAGNESIUM STEARATE
• POWDERED CELLULOSE
• STARCH, CORN
• LOPERAMIDE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 27 matching rows.

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Orange Book products#

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.