Sodium Bicarbonate Tablet
FDA Label NDC 55154-6754

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Sodium Bicarbonate (NDC 55154-6754). 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, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Drug Facts

In each tablet: Sodium Bicarbonate 10 gr (650 mg)

Purpose

Antacid

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.

Uses

Indications: Relieves ·acid indigestion ·heartburn ·sour stomach ·upset stomach associated with these symptoms

Warnings

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 the 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: Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

Directions

  • 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.

Inactive Ingredients

Pregelatinized starch, NF and mineral oil, USP.

Other

·Each tablet contains: sodium 178 mg (7.74 meq)

·Store at room temperature 15° - 30°C (59° - 86°F) in well-closed containers as defined in the USP.

Questions ? 1-815-877-6480

Manufactured For and Distributed By: Hospak® Unit Dose Products, Huntley, IL 60142

Distributed By:

Cardinal Health

Dublin, OH 43017

L40866170518

Rev. 8/17

Principal Display Panel

Sodium Bicarbonate

10 gr (650 mg)

Antacid Tablets

10 Tablets

Bag Label (Ed9fa8c5 16ec 4f73 Af89 B4c7da753c09 00)

Bag Label (Ed9fa8c5 16ec 4f73 Af89 B4c7da753c09 00)

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