SODIUM BICARBONATE tablet

Sodium Bicarbonate by

Drug Labeling and Warnings

Sodium Bicarbonate by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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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 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.

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

PRINCIPAL DISPLAY PANEL

NDC: 10135-684-10

Marlex Pharmaceuticals, Inc.

Sodium Bicarbonate

Sodium Bicarbonate 5 gr (325 mg) Antacid

1000 Tablets

PRINCIPAL DISPLAY PANEL

NDC: 10135-685-10

Marlex Pharmaceuticals, Inc.

Sodium Bicarbonate

Sodium Bicarbonate 10gr (650 mg) Antacid

1000 Tablets

INGREDIENTS AND APPEARANCE

SODIUM BICARBONATE 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-684
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	G37
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-684-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	03/01/2020

SODIUM BICARBONATE 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-685
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	650 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	G57
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-685-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	03/01/2020

Labeler - Marlex Pharmaceuticals Inc (782540215)