FDA.reportPublic FDA data

Tumeez Organic Apple

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)

Brand name
Tumeez Organic Apple
Generic name
CALCIUM CARBONATE
Manufacturer
BFY LLC
Product type
HUMAN OTC DRUG
SPL set ID
f561685a-5260-59c6-e053-2a95a90ae206
SPL ID
59e3f013-4da4-88cc-e063-6294a90ab5cf
Version
14
Effective date
2026-08-25
Source export date
2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:56:28
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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

Warnings sections page 1 of 9 · 36 matching rows.

warnings

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if: sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

warnings

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

warnings

Warnings Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days irritation, pain, or redness persists or worsens Keep out of reach of children.

warnings

Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. Stop use and ask a doctor if sore throat does not improve in 7 days. irritation, pain, or redness persists or worsens. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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