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Sodium Bicarbonate by Rugby Laboratories, Inc.

Dosage form: tablet
Ingredients: Sodium Bicarbonate 325mg
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-4540

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.

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

Enter section text here

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.

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4540
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Bicarbonate (Sodium Cation) Sodium Bicarbonate325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM  
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Tablet) Size9mm
FlavorImprint Code120
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-4540-101000 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/21/2010
Labeler - Rugby Laboratories, Inc. (109178264)
Registrant - Advance Pharmaceutical, Inc. (187824339)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical, Inc.187824339manufacture, repack, relabel

Revised: 11/2010
 
Rugby Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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