FDA label fa3ddce8-4c81-44d6-b6fb-24a205b2f5cc

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
a5afd52f-4cda-41ed-bb5d-c8b4c33a1f58
SPL ID
fa3ddce8-4c81-44d6-b6fb-24a205b2f5cc
Version
1
Effective date
2013-04-09
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:30:59

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 Do not use in case of renal insufficiency if hypersensitive to chromium Ask a doctor before use in thyroid conditions in children younger than 2 years When using this product In very rare cases, skin reactions may occur after use. In these cases discontinue use of product. In rare cases, hypersalivation may occur after administration. In these cases discontinue use of product. Stop use and ask a doctor if pain persists for more than one week (5 days in children) fever persists for more than 3 days symptoms worsen new symptoms occur redness or swelling is present sore throat is severe and persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting If pregnant or breastfeeding , ask a health care professional before use. Keep out of reach of children. Directions Adults and children ≥ 12 years 5-10 drops; children (6-11 years) 3-5 drops; children (2-5 years) 2-3 drops, all ages take 2-3 times daily in a little water or undiluted or as recommended. In acute cases (see age group) the same dosage up to 6 times per day. Not recommended for children under 2 years of age except under the advice of a health care professional. Other information Tamper resistant: do not use if safety ring at base of cap is broken. Retain outer carton for full product information.

Reported adverse events (FAERS/openFDA)#

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