Sodium Bicarbonate 10 Gr (650 Mg)

Sodium Bicarbonate 10 Gr (650 Mg)
SPL v1
SPL
SPL Set ID 15605a6d-6c90-47d5-9d1f-f66a3f27d5fc
Route
ORAL
Published
Effective Date 2016-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (650 mg)
Inactive Ingredients
Croscarmellose Sodium Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AP;119 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-05-01
Description

Active Ingredient (in each tablet) Sodium bicarbonate 10 gr (650 mg)

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Active Ingredient (in each tablet) Sodium bicarbonate 10 gr (650 mg)

Section 34088-5

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Section 50565-1

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Section 53414-9

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

Drug Facts

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Directions:
  • Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours
  • Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours
  • Dissolve tabelt completely in water before drinking.
  • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.
Indications:

Relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Other Information:
  • each tablet contains: sodium 178 mg 
  • store at room temperature 15 °- 30 °C (59 °- 86 °F).
Inactive Ingredient

croscarmellose sodium, microcrystalline cellulose, stearic acid

Questions Or Comments

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

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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:

Count 650 mg
60 43353-162-53
90 43353-162-60
120 43353-162-70
180 43353-162-80
200 43353-162-85
360 43353-162-94

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:



Cookeville, TN 38506



20171213JH

Ask A Doctor Or Pharmacist
  • if you are on a sodium-restricted diet.
  • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
  • if symptons last more than 2 weeks
Principal Display Panel 650 Mg

NDC 43353-162 - Sodium Bicarbonate 650 mg - Rx Only

Structured Label Content

Section 34088-5 (34088-5)

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Section 50565-1 (50565-1)

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Section 53414-9 (53414-9)

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

Purpose (PURPOSE)

Antacid

Drug Facts

Active Ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Directions:
  • Adults 60years of age and over - 1-2 tablets every 4 hours. Not more than 12 tablets in 24 hours
  • Adults under 60 years- 1-4 tablets every4 hours. Not more than 24 tablets in 24 hours
  • Dissolve tabelt completely in water before drinking.
  • DO NOT EXCEED RECOMMENDED DOSE. Not recommended for children.
Indications:

Relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Other Information:
  • each tablet contains: sodium 178 mg 
  • store at room temperature 15 °- 30 °C (59 °- 86 °F).
Inactive Ingredient (INACTIVE INGREDIENT)

croscarmellose sodium, microcrystalline cellulose, stearic acid

Questions Or Comments (Questions or Comments)

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

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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:

Count 650 mg
60 43353-162-53
90 43353-162-60
120 43353-162-70
180 43353-162-80
200 43353-162-85
360 43353-162-94

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:



Cookeville, TN 38506



20171213JH

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)
  • if you are on a sodium-restricted diet.
  • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
  • if symptons last more than 2 weeks
Principal Display Panel 650 Mg (PRINCIPAL DISPLAY PANEL - 650 mg)

NDC 43353-162 - Sodium Bicarbonate 650 mg - Rx Only

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.347376 · Updated: 2026-03-14T22:54:56.160161