warnings
Do not use if you have difficulty swallowing in children under 6 years of age if you are pregnant for a period longer than week if you are bedridden or aged
FDA label 63df21c4-4ae7-466c-a9e2-16227f674f70
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
- SPL set ID
- fb70a630-ff36-4600-996b-7a1338da277b
- SPL ID
- 63df21c4-4ae7-466c-a9e2-16227f674f70
- Version
- 8
- Effective date
- 2020-06-01
- Source export date
- 2026-10-12
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:51:18
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 63df21c4-4ae7-466c-a9e2-16227f674f70 | id | |
| spl set id | fb70a630-ff36-4600-996b-7a1338da277b | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse reaction Distributed by: SELECT BRANDS DISTRIBUTORS Pine Bluff, AR 71603 AC (870)535-3635 831.000/831AA
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.