OTC Medication Information: Sodium Bicarbonate

SODIUM BICARBONATE- sodium bicarbonate tablet
Aphena Pharma Solutions — Tennessee, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SODIUM BICARBONATE – sodium bicarbonate tablet

Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Sodium Bicarbonate

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

Warnings

Ask a doctor before use if you have

a sodium restricted diet

Ask a doctor or p harmacist before use if you are

taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doc tor if

symptoms last more than 2 weeks

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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
Cookeville, TN 38506
20200723JH

PRINCIPAL DISPLAY PANEL — 650 mg

NDC 71610-445 — Sodium Bicarbonate 650 mg Tablets

Bottle Label 650 mg
(click image for full-size original)

SODIUM BICARBONATE
sodium bicarbonate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-445(NDC:10135-685)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 650 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MINERAL OIL
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code G57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-445-53 60 TABLET in 1 BOTTLE None
2 NDC:71610-445-60 90 TABLET in 1 BOTTLE None
3 NDC:71610-445-80 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 03/01/2020
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-445)

Revised: 07/2020 Aphena Pharma Solutions — Tennessee, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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