Drug Facts for Sodium Bicarbonate 325 mg

Drug Labeling and Warnings

Drug Details [pdf]

SODIUM BICARBONATE- sodium bicarbonate tablet 
Rugby Laboratories, 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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Drug Facts for Sodium Bicarbonate 325 mg

Active ingredient(in each tablet) Purpose

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Sodium bicarbonate 5 gr (325 mg) ..............................Antacid

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Inactive ingredients

croscarmellose sodium, microcrystalline cellulose, stearic acid

Warnings

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Ask a doctor before use if you have a sodium restricted diet

Other information

• each tablet contains: sodium 89 mg
• store at room temperature 15o - 30o C(59o -86o F)
  

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Ask a doctor or pharmacist before use if you are

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

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• do not use the maximum dosage for more than two weeks
• tablets may be swallowed whole or dissolved in water prior to use

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

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Keep out of reach of children.

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If pregnant or breast-feeding, ask a health professional before use.

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Uses relieves

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

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Questions or comments?

call 1-800-645-2158, 9am-5pm ET, Monday-Friday

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Stop use and ask a doctor if symptoms last for more than 2 weeks

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Directions

• adults 60 years of age and over: 2-4 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

tablets may be swallowed whole of dissolved in water prior to use

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Uses

relieves

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

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Ask a doctor before use of 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.

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Tablets may be swallowed whole or dissolved in water prior to use.

Adults 60 years of age and over: 2 - 4 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.

Principal Display Panel

Sodium Bicarbonate

5 Gr (325 mg)

1000 Tablets

SODIUM BICARBONATE 
sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-4540
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Tablet)	Size	9mm
Flavor		Imprint Code	120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-4540-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2010	07/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	04/21/2010	07/31/2018

Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 9/2019

Document Id: 395e3107-b1ce-4378-b62e-05adf6237ab8

34390-5

Set id: e60be9cd-c0aa-442b-93ae-6500c07d919d

Version: 4

Effective Time: 20190910

 

Rugby Laboratories, Inc.