ANTACID EXTRA STRENGTH- calcium carbonate tablet, chewable 
Western Family Foods 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.

----------

Western Family Antacid 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

Principal Display Panel

Antacid

EXTRA Strength

Calcium Carbonate 750 mg

Antacid/Calcium Supplement

Calcium

Assorted Fruit

NATURALLY AND ARTIFICIALLY FLAVORED

COMPARE TO TUMS® EXTRA STRENGTH 750 active ingredient

Antacid Front Label

Antacid Front Label

Antacid Back Label

Antacid Front Label

Antacid Back Label

ANTACID  EXTRA STRENGTH
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-179
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:55312-179-8096 in 1 BOTTLE; Type 0: Not a Combination Product10/31/200110/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/31/200110/01/2017
Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017
Document Id: 0f61f45a-e636-496b-9722-c284868a2b83
Set id: 8b76a0f3-68d8-41b4-9d66-bc8bde889605
Version: 2
Effective Time: 20171127
 
Western Family Foods Inc