Sodium Bicarbonate Tablet
FDA Label NDC 77333-831

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Sodium Bicarbonate (NDC 77333-831). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - do not use, warnings and precautions, drug interactions, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Do Not Use

  • Do not use this product if you are on a sodium-restricted diet unless directed by a doctor. Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 years of age or older) in a 24 hour period nor use maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product

Warnings And Precautions

  • Stomach Warning: TO AVOID SERIOUS INJURY, D0 NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

Drug Interactions

  • Drug Interaction Precaution: Ask a physician or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs

Otc - Keep Out Of Reach Of Children

  • KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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