SODIUM BICARBONATE- sodium bicarbonate tablet 
Major Pharmaceuticals

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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4624 - Major

Drug Facts

Active ingredient (in each tablet)

Sodium bicarbonate 10 gr (650 mg)

Purpose

Antacid

Uses

relieves:

 acid indigestion

 heartburn

 sour stomach
 upset stomach associated with these symptoms

Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for
adults 60 years of age and older) in a 24-hour period nor use the maximum dosage
for more than 2 weeks, except under the advice and supervision of a physician.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

 do not use the maximum dosage for more than 2 weeks  tablets may be
swallowed whole or dissolved in water prior to use  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 178 mg
 store in a dry place at 15° – 30°C (59° – 86°F)  Retain this carton for
important information.

croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc

Questions or comments?

(800) 616-2471

Unit Dose

Sodium Bicarbonate

DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
www.majorpharmaceuticals.com

WARNING: This product can expose you to chemicals including
lead, which is known to the State of California to cause cancer
and birth defects or other reproductive harm. For more information
go to www.P65Warnings.ca.gov.

NDC 0904-7261-61

MAJOR®

Unit Dose

Sodium Bicarbonate

Antacid

10 gr (650 mg)

100 Tablets

Major Label

SODIUM BICARBONATE 
sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7261
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code CPC;77
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7261-6110 in 1 BOX, UNIT-DOSE10/26/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/26/2022
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2022
Document Id: ebf340c9-0b6e-13d2-e053-2995a90ae338
Set id: ebf340c9-0b6d-13d2-e053-2995a90ae338
Version: 1
Effective Time: 20221026
 
Major Pharmaceuticals