Loperamide Hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

• controls the symptoms of diarrhea, including Traveler's Diarrhea

Warnings

WARNINGS SECTION

Alergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use if you have bloody or black stool

Ask a doctor before use if you have

• high fever (greater than 101°F)
• mucus present in your stool
• a history of liver disease

Ask doctor or pharmacist before use if you are taking antibiotics

Stop use and ask a doctor if diarrhea lasts for more than 2 days

If pregnant or breast-feeding, 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• use enclosed dosage cup to accurately measure dosage as noted below
• drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
• find right dose on chart. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and older	4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a day
children 9-11 years (60-95 lbs)	2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a day
children 6-8 years (48-59 lbs)	2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a day
children under 6 years (up to 47 lbs)	ask a doctor (not intended for use in children under 6 years old)

Other information

SPL UNCLASSIFIED SECTION

• avoid excess heat
• store at room temperature, 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-262-9010

Mon. - Thurs. 9:00 am - 4:30 pm EST,

Fri. 9:00 am - 2:30 pm EST

Serious side effects associated with use of this product may be reported to this number.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 618:05 4/12

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0461

NDC: 50090-0461-0 118 mL in a BOTTLE

Loperamide Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

• Loperamide Hydrochloride
• LOPERAMIDE
• ALCOHOL
• ANHYDROUS CITRIC ACID
• BENZOIC ACID
• CHERRY
• GLYCERIN
• MINT
• PROPYLENE GLYCOL
• SODIUM BENZOATE
• SORBITOL
• SUCROSE
• WATER

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

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#

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 · 44 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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