Extra Strength Antacid

Extra Strength Antacid is an FDA-registered drug product whose active ingredient is CALCIUM CARBONATE. It is labelled by PuraCap Pharmaceutical LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 51013-323, application part331, label effective 20171213. 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: relieves heartburn, acid indigestion, sour stomach. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions adults and children 12 years of age and over : chew 2 - 4 tablets as symptoms occur, or as directed by a doctor do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Extra Strength Antacid used for?
Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Who makes Extra Strength Antacid?
PuraCap Pharmaceutical LLC is the labeler of record for Extra Strength Antacid. 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 Extra Strength Antacid 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 Extra Strength Antacid 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 Extra Strength Antacid been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.