FDA label 48354f4f-3b95-4da4-b60d-ac97618fae04
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
- 61801c3a-caf2-4bb7-a56a-dc2ee007eccb
- SPL ID
- 48354f4f-3b95-4da4-b60d-ac97618fae04
- Version
- 7
- Effective date
- 2022-02-18
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:13:59
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 | 48354f4f-3b95-4da4-b60d-ac97618fae04 | id | |
| spl set id | 61801c3a-caf2-4bb7-a56a-dc2ee007eccb | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS If patient has been given ipecac syrup, DO NOT give ACTIDOSE ® WITH SORBITOL or ACTIDOSE ® -AQUA until after last vomiting episode. Do not use in persons who are not fully conscious. Do not use this product unless directed by a health professional, if turpentine, corrosives, such as alkalies (lye) and strong acids, or petroleum distillates, such as kerosene, gasoline, paint thinner, cleaning fluid or furniture polish, have been ingested. This product is not recommended for use in children weighing less than 32 kg, or during multiple dose activated charcoal therapy since excessive catharsis and significant fluid and electrolyte abnormalities may occur. Keep this and all drugs out of the reach of children. Do not use Actidose ® with Sorbitol or Actidose ® -Aqua in any person known to have a rare autosomal recessive genetic intolerance to fructose. Do not use Actidose ® with Sorbitol in patients who are dehydrated. Actidose ® with Sorbitol may cause excessive diarrhea.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Activated charcoal with sorbitol has produced severe hypernatremic dehydration when used in excessive amounts in pediatric patients. 25, 27 Aspiration of activated charcoal has been reported to produce airway obstruction and a limited number of fatalities have occurred. 28,29,30,31 Bronchiolitis obliterans resulting in death has developed several weeks after the aspiration of activated charcoal. 32 Gastrointestinal obstruction associated with the use of multiple dose activated charcoal therapy has been reported. 33 An overdose of carbamazepine was responsible for the antiperistaltic effects which led to bowel obstruction.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.