SODIUM BICARBONATE ANTACID- sodium bicarbonate tablet 
Cardinal Health

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 650 mg

Drug Facts

Active ingredient                                           Purpose

(in each tablet)

Sodium bicarbonate 10 gr (650 mg) .......      Antacid

Purpose                      Antacid

Keep out of reach of children.

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 of 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.

This package for households without young children. This package is intended for in-patient institutional use only. This package is not child resistant.

Each tablet contains: sodium 178 mg

Directions

•
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
•
do not use the maximum dosage for more than 2 weeks
•
tablets may be swallowed whole or dissolved in water prior to use

Inactive ingredients

croscarmellose sodium, microcrystalline cellulose, stearic acid

Storage

store at room temperature 15o - 30o C (59o - 86o F)

Questions or comments?

call 1-800-645-2158

Distributed by: Rugby Laboratories

31778 Enterprise Drive, Livonia, MI 48150

www.rugbylaboratories.com

Rugby is a trademark owned by its respective owner.

Repackaged by: Cardinal Health

Zanesville, OH 43701

LFC4921292-11013E

LFC4921292-21013E

Principal Display Panel

Principal Display Panel

Sodium Bicarbonate Antacid Tablet

10 gr (650 mg)

Pouch label

Principal Display Panel

Principal Display Panel

Sodium Bicarbonate Antacid Tablet

10 gr (650 mg)

500 White Tablets

Carton Label
SODIUM BICARBONATE ANTACID 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6815(NDC:0536-4544)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation - UNII:LYR4M0NH37) Sodium Bicarbonate650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Tablet) Size11mm
FlavorImprint Code 119
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6815-4500 in 1 CARTON03/08/201009/30/2014
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/08/201009/30/2014
Labeler - Cardinal Health (188557102)
Registrant - Advance Pharmaceutical, Inc. (187824339)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6815)

Revised: 6/2018
Document Id: 613aea71-7d99-46b0-94de-f8bfb184e81e
Set id: a13d04f1-ee16-4733-b379-eb61ef3c0d09
Version: 2
Effective Time: 20180621
 
Cardinal Health