Sodium Bicarbonate
FDA Label NDC 71610-445

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Sodium Bicarbonate (NDC 71610-445). 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, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Sodium bicarbonate 10 gr (650 mg)

Sodium bicarbonate 5gr (325 mg)

Purpose

Antacid

Uses

Relieves

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

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.

Directions

  • do not use the maximum dosage for more than 2 weeks
  • dissolve tablets completely in water prior to use

    • 325mg,

    • adults 60 years of age and over: 2-8 tablets every 4 hours, not more than 24 tablets in 24 hours
    • adults under 60 years of age: 2-8 tablets every 4 hours, not more than 48 tablets in 24 hours

      • 650mg,

      • 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

Other Information

  •  each tablet contains: sodium 89mg (325mg) 
  • store at room temperature 15°-30°C (59°-86°F) in well-closed containers as defined in the USP

    •      sodium 178 mg (650mg) 

Inactive Ingredients

Pregelatinized starch, NF and mineral oil, USP

Questions Or Comments?

Call toll free 1-888-266-8818

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count650 mg
6071610-445-53
9071610-445-60
18071610-445-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Aphena Pharma Solutions (TN)

Aphena Pharma Solutions (TN)


Cookeville, TN 38506

20200723JH

Principal Display Panel - 650 Mg

NDC 71610-445 - Sodium Bicarbonate 650 mg Tablets

Bottle Label 650 mg (71610 0445 53)

Bottle Label 650 mg (71610 0445 53)

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