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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Select Brand Ultra Strength Assorted Fruit Antacid Tablets

Active ingredient (in each tablet)

Calcium carbonate 1000 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 prescription drugs.

When using this product

do not take more than 8 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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Compare to the active ingredient in TUMS® ULTRA

Antacid Tablets

Ultra Strength

Assorted Fruit

Naturally and Artificially Flavored

72 CHEWABLE TABLETS

Ultra Assoted Fruit front label

ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-955
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1000 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
ShapeROUNDSize17mm
FlavorFRUIT (orange, cherry, lemon, lime) Imprint Code G171
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-955-7272 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: 0c40d932-b31c-4da3-ae13-d9b6ae7c507f
Set id: 5c3cf524-d6e6-4727-91e5-6921c7946120
Version: 1
Effective Time: 20141002
 
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