Sodium Bicarbonate 10 gr. (650 mg)

Sodium Bicarbonate 10 gr. (650 mg) is an FDA-registered drug product whose active ingredient is SODIUM BICARBONATE. It is labelled by Gendose Pharmaceuticals, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 77333-829, application M001, label effective 20260413. It is one of 33 FDA drug label records sharing the active ingredient SODIUM BICARBONATE. 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 SODIUM BICARBONATE are most often described in connection with: relieves acid, indigestion heartburn, sour stomach. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms

Directions do not use the maximum dosage for more than 2 weeks tablets may be swallowed whole or dissolved in water prior to use adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours

Warnings Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age and older) in a 24-hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. Ask a doctor before use if you have a sodium restricted diet. Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

FDA lists 33 drug label records with SODIUM BICARBONATE 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 Sodium Bicarbonate 10 gr. (650 mg) used for?
Uses relieves acid indigestion heartburn sour stomach upset stomach associated with these symptoms

Who makes Sodium Bicarbonate 10 gr. (650 mg)?
Gendose Pharmaceuticals, LLC is the labeler of record for Sodium Bicarbonate 10 gr. (650 mg). 33 FDA label records share the active ingredient SODIUM BICARBONATE, 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 Sodium Bicarbonate 10 gr. (650 mg) 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 Sodium Bicarbonate 10 gr. (650 mg) 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 SODIUM BICARBONATE?
Yes. 33 FDA drug label records list SODIUM BICARBONATE 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 Sodium Bicarbonate 10 gr. (650 mg) 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.