Sodium Bicarbonate Tablet
FDA Label NDC 69367-258

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Sodium Bicarbonate (NDC 69367-258). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, stomach warning, drug interaction precaution, 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

Other

Drug Facts

Active Ingredient (In Each Tablet)

Sodium Bicarbonate 10 gr (650 mg)

Purpose

Antacid

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

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 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. As with any drug, if you are pregnant or nursing a baby, seek advice of a health professional before using this product.

Stomach Warning

TO AVOID SERIOUS INJURY, DO 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 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.

Adults

Take 1 tablet, dissolved in a glass of water, as needed. Maximum daily dose for adults up to 60 years of age is 24 tablets. Maximum daily dose for adults 60 years of age or older is 12 tablets. Dissolve completely in water before drinking.

DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.

Other Information

  • each tablet contains: sodium 178 mg (7.74 mEq)
  • store at room temperature 15°-30°C (59°-86°F) in a well-closed container as defined in the USP

Inactive Ingredients

Microcrystalline cellulose and stearic acid

Questions Or Comments?

Call 1-844-221-7294 M-F (9 a.m. to 5 p.m. EST)

Principal Display Panel - 1000 Tablet Bottle Label

NDC 69367-258-10

Sodium Bicarbonate
Tablets, USP

10 gr (650 mg)

ANTACID

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN.

1000 Tablets

Westminster
Pharmaceuticals

Principal Display Panel (1000 Tablet Bottle Label)

Principal Display Panel (1000 Tablet Bottle Label)

* Please review the disclaimer below.