Hyoscyamine Sulfate TAB
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
- Brand name
- Hyoscyamine Sulfate TAB
- Generic name
- HYOSCYAMINE SULFATE
- Manufacturer
- QPharma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- fc7566e6-c043-fcd4-e053-6294a90a77e5
- SPL ID
- 46539e99-e8c6-7994-e063-6294a90a0a7c
- Version
- 3
- Effective date
- 2025-12-16
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:38:31
| Harmonized routes |
|---|
| ORAL |
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 |
|---|---|---|---|
| brand name | Hyoscyamine Sulfate TAB | openfda.brand_name | |
| generic name | HYOSCYAMINE SULFATE | openfda.generic_name | |
| manufacturer name | QPharma, Inc. | openfda.manufacturer_name | |
| ndc | package | 42708-183-56 | openfda.package_ndc |
| ndc | product | 42708-183 | openfda.product_ndc |
| ndc11 | package | 42708018356 | derived:openfda.package_ndc |
| rxcui | 1047905 | openfda.rxcui | |
| spl id | 46539e99-e8c6-7994-e063-6294a90a0a7c | id | |
| spl set id | fc7566e6-c043-fcd4-e053-6294a90a77e5 | set_id | |
| unii | F2R8V82B84 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic/ antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); and decreased sweating.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.