Official product label reference

Loperamide Hydrochloride — YYBA CORP

This page contains 15 source sections for LOPERAMIDE HYDROCHLORIDE, oral route. Label set 5a728c6d-26ec-3316-e063-6394a90ade08, version 3.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Purpose

Purpose Anti-diarrheal

Dosage and administration — label text

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 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

Warnings

Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride Heart alert: Taking more than directed can cause serious heart problems or death

Active ingredient

Active ingredient (in each capsule) Loperamide Hydrochloride USP, 2 mg

Do not use

Do not use if you have bloody or black stool in children under 12 years of age

Ask a doctor before use

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

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

While using this medicine

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

When to stop use and seek help

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.

Pregnancy or breast feeding

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

Child safety

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).

Unclassified section

Other information store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light. do not use if carton or blister unit is open or torn avoid excessive heat above 40°C (104°F) see side panel for lot number and expiration date FDA approved dissolution test specifications differ from USP.

Inactive ingredient

Inactive ingredients butylated hydroxyanisole, gelatin, glycerin, glyceryl monocaprylate, neelicert FD&C Blue No.1, polyoxyl 40 hydrogenated castor oil, purified water

Questions

Questions or comments? call toll free 866-933-6337

Official sources and product identifiers

DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
Drugs@FDA application ANDA220372Application history where available; verify the specific product and indication.

Substances listed: LOPERAMIDE HYDROCHLORIDE

RxNorm identifiers: 978006

Package NDC codes

73581-177-02

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.

Loperamide Hydrochloride drug information