FDA label 7755b54b-6083-247b-e053-2a91aa0ae1e8

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
52a89560-bfd2-491a-e054-00144ff88e88
SPL ID
7755b54b-6083-247b-e053-2a91aa0ae1e8
Version
3
Effective date
2018-10-03
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:26

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

Warning Allergy alert do not use this product if your baby has a history of allergy to clove, its component eugenol, or to Balsam of Peru. Do not use more than directed for more than 7 days unless directed by a dentist or doctor When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness does not go away swelling, rash or fever develops Warning

Reported adverse events (FAERS/openFDA)#

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