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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.