ANTACID- calcium carbonate tablet, chewable 
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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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Antacid Tablets Regular Strength Assorted Fruit

Active ingredient (in each tablet)

Calcium carbonate 500 mg

Purpose

Antacid

Uses

relieves

Warnings


Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacids may interact with certain prescriptiom drugs.

When using this product

do not take more than 16 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Keep out of reach of children


Directions

Other information

Inactive ingredients

adipic acid, corn starch, crospovidone, red 27 lake,  red 30 lake,  Yellow 10 lake, dextrose,  blue 1 lake, yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

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Antacid Tablets

Regular Strength

Assorted Fruit

Compare to the Active Ingredient in Tums®

Naturally and Artificially Flavored

150 chewable tablets

LABEL

ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID (UNII: 76A0JE0FKJ)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 68401960MK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colororange, yellow, green, pink (reddish pink) Scoreno score
ShapeROUNDSize16mm
FlavorFRUIT (Orange, cherry, lemon, lime) Imprint Code GDC126
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-211-24150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/12/2008
Labeler - Select Brand (043562370)

Revised: 10/2014
Document Id: db8374db-0a7e-471f-8760-411a2da55d7b
Set id: abb898aa-0c01-40df-9462-ec08c0e56c71
Version: 2
Effective Time: 20141001
 
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