ANTACID EXTRA STRENGTH- calcium carbonate tablet, chewable 
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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Major Pharmacuticals Antacid Tablets Drug Facts

Active ingredient (in each tablet)

Calcium carbonate USP 750mg

Purpose

Antacid

Uses

relieves

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

Warnings

Ask a doctor before use if you have

•
kidney stones
•
a calcium-restricted diet

Ask a doctor or pharmacist before use if you are

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

When using this product

•
do not take more than 10 tablets in 24 hours
•
do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

Directions

•
chew 2 - 4 tablets as symptoms occur, or as directed by a doctor

Other information

•
each tablet contains: calcium 320 mg and magnesium 10 mg
•
store at 20-25°C (68-77°F)

Inactive ingredients

adipic acid, blue #1 aluminum lake, dextrose, flavors, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, red #40 aluminum lake, talc, yellow #5 aluminum lake (tartrazine), yellow #6 aluminum lake

Questions?

1-800-616-2471

Principal Display Panel

COMPARE TO the active ingredient of TUMS® EXTRA STRENGTH 750

CALCIUM

Antacid Tablets

Extra Strength

ANTACID/CALCIUM SUPPLEMENT

Calcium Carbonate 750 mg

Assorted Fruit

Naturally & Artificially Flavored

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Antacid Tablets Front Label

Antacid Tablets Front Label

Antacid Tablets Back Label

Antacid Tablets Front Label

Antacid Tablets Back Label

ANTACID  EXTRA STRENGTH
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7695
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID (UNII: 76A0JE0FKJ)  
DEXTROSE (UNII: IY9XDZ35W2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MINERAL OIL (UNII: T5L8T28FGP)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
TALC (UNII: 7SEV7J4R1U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorYELLOW, GREEN, RED, ORANGEScoreno score
ShapeROUNDSize17mm
FlavorFRUIT (lemon, orange, cherry, lime) Imprint Code L179
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7695-9196 in 1 BOTTLE; Type 0: Not a Combination Product05/02/199406/17/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/02/199406/17/2013
Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2017
Document Id: bd89e74a-47e5-441b-85c9-71e4846c7122
Set id: 4d4399c2-ac65-4ec4-b846-ee2fcf25c618
Version: 4
Effective Time: 20171125
 
Major Pharmaceuticals