FDA label d4ed90b2-b567-4630-923a-3ccbe6850fb6

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
12062a2e-cb58-419a-b97a-0d04a8d774f6
SPL ID
d4ed90b2-b567-4630-923a-3ccbe6850fb6
Version
2
Effective date
2016-01-25
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:18

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Stop use and ask a doctor if: Swelling, rash, or fever develop. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting occurs. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. Keep out of reach of children under 3 years of age.

warnings

Warnings Stop use and ask a doctor if: Gingivitis, bleeding, or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms or periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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