ANTACIDEXTRA STRENGTH EXTRA STRENGTH- calcium carbonate tablet, chewable 
REMEDYREPACK 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.

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Major Pharmacuticals Antacid Tablets Drug Facts

OTC - ACTIVE INGREDIENT

Calcium carbonate USP 750mg

 

OTC - PURPOSE

Antacid

 

INDICATIONS & USAGE

relieves

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

 

WARNINGS

  • kidney stones
  • a calcium-restricted diet

 

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

 

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

 

DOSAGE & ADMINISTRATION

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

 

STORAGE AND HANDLING

  • each tablet contains: calcium 300 mg and magnesium 1 mg
  • store below 30°C (86°F)

 

INACTIVE INGREDIENT

adipic acid, blue #1 aluminum lake, dextrose, flavors, magnesium stearate, maltodextrin, starch, sucrose, red #27 aluminum lake, starch, yellow #10 aluminum lake, yellow #6 aluminum lake

 

OTC - QUESTIONS

1-800-616-2471

 

OTC - KEEP OUT OF REACH OF CHILDREN



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: antacidextra strength extra strength


GENERIC: Calcium carbonate


DOSAGE: TABLET, CHEWABLE


ADMINSTRATION: ORAL


NDC: 61786-215-61


ACTIVE INGREDIENT(S):

  • CALCIUM CARBONATE 750mg in 1


INACTIVE INGREDIENT(S):

  • ADIPIC ACID
  • D&C RED NO. 27
  • FD&C BLUE NO. 1
  • FD&C YELLOW NO. 6
  • D&C YELLOW NO. 10
  • DEXTROSE
  • MAGNESIUM STEARATE
  • MALTODEXTRIN


COLOR: yellow


FLAVOR: FRUIT


SHAPE: ROUND


SCORE: No score


SIZE: 17 mm


IMPRINT: L179


PACKAGING: 96 in 1 BOTTLE




MM1

MM2

ANTACIDEXTRA STRENGTH  EXTRA STRENGTH
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-215(NDC:0904-7695)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID (UNII: 76A0JE0FKJ)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
Coloryellow, red, orange, greenScoreno score
ShapeROUND (TABLET, CHEWABLE) Size17mm
FlavorFRUITImprint Code L179
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-215-6196 in 1 BOTTLE; Type 0: Not a Combination Product03/10/201503/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/10/201503/16/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.