FDA label 4ce5c14a-4fd5-4006-9d32-338c277bc424

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
9eef79e6-3655-4b9b-93c0-b32c6e7ae0ba
SPL ID
4ce5c14a-4fd5-4006-9d32-338c277bc424
Version
3
Effective date
2015-05-04
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:33

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 Reye’s Syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy Alert : Contains salicylate. Do not take if you are ■ allergic to salicylates (including aspirin) ■ taking other salicylate products Do Not Use if you have ■ bloody or black stool ■ an ulcer ■ a bleeding problem Ask a Doctor before use if you have ■ fever ■ mucus in the stool Ask a Doctor/Pharmacist before use if you are taking any drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis Stop Use and ask a doctor if ■ symptoms get worse ■ ringing in the ears or loss of hearing occurs ■ diarrhea lasts more than 2 days When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. If pregnant or breast-feeding, ask a health professional before use. Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ Adults and Children 12 years and over: 525 mg (2 tablets) every 1/2 to 1 hour or 1050mg (4 tablets) every hour as needed ■ do not exceed 4200 mg (16 tablets) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ Children under 12 years: ask a doctor Other information ■ save carton for full directions and warnings ■ store at room temperature 59°- 86°F (15°-30°C) ■ do not use if cellophane unit is torn ■ Phenylketonurics: contains phenylalanine 1.1 mg per tablet ■ Calcium content per tablet: 73 mg Inactive ingredients aspartame, calcium carbonate, D&C red #27, dextrates, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide.

Reported adverse events (FAERS/openFDA)#

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