FDA label b48ec21f-0c86-4f28-9731-cd3169d520ff

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: 464ce170-b7b4-47d6-8b16-a264daafdad4
SPL ID: b48ec21f-0c86-4f28-9731-cd3169d520ff
Version: 4
Effective date: 2009-10-20
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:34:24

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		b48ec21f-0c86-4f28-9731-cd3169d520ff	id
spl set id		464ce170-b7b4-47d6-8b16-a264daafdad4	set_id

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Boxed warning sections page 1 of 1 · 1 matching rows.

boxed warning

Children under 6 years old (up to 47 lbs): Consult a physician. Not intended for use in children under 6 years old.

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Do not use for more than two days unless directed by a physician. DO NOT USE IF DIARRHEA IS ACCOMPANIED BY HIGH FEVER (GREATER THAN 101°F), OR IF BLOOD OR MUCUS IS PRESENT IN THE STOOL, OR IF YOU HAVE HAD A RASH OR OTHER ALLERGIC REACTION TO LOPERAMIDE HYDROCHLORIDE. If you are taking antibiotics or have a history of liver disease, consult a physician before using this product. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Store at Room Temperature 15°-30°C (59°-86°F).

Reported adverse events (FAERS/openFDA)#

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