Tumeez Organic Apple

Tumeez Organic Apple is an FDA-registered drug product whose active ingredient is CALCIUM CARBONATE. It is labelled by BFY LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 72427-2000, application M001, label effective 20260825. It is one of 78 FDA drug label records sharing the active ingredient CALCIUM CARBONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CALCIUM CARBONATE are most often described in connection with: temporary relief, minor discomfort. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for temporary relief of minor discomfort of the throat

Directions Adults and children 3 years of age and older: Allow one pop to dissolve slowly in mouth May be repeated as needed or as directed by a doctor Children under 3 years of age: ask a doctor

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.

FDA lists 78 drug label records with CALCIUM CARBONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Tumeez Organic Apple used for?
Uses for temporary relief of minor discomfort of the throat

Who makes Tumeez Organic Apple?
BFY LLC is the labeler of record for Tumeez Organic Apple. 78 FDA label records share the active ingredient CALCIUM CARBONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Tumeez Organic Apple come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Tumeez Organic Apple prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CALCIUM CARBONATE?
Yes. 78 FDA drug label records list CALCIUM CARBONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Tumeez Organic Apple been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.