PLUS PHARMACALCIUM ANTACID CALCIUM ANTACID- 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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Drug Facts

OTC - ACTIVE INGREDIENT

Calcium Carbonate, USP 500 mg

 

OTC - PURPOSE

Antacid

 

INDICATIONS & USAGE

for the relief of

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

 

WARNINGS

Do not take more than 15 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.

 

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

 

ask a doctor before use.

 

 

DOSAGE & ADMINISTRATION

Adults and children 12 years and older

  • Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a doctor

Children under 12 years

  • Do not give to children under 12 years unless directed by a doctor

 

SPL UNCLASSIFIED

  • Each tablet contains: Elemental Calcium 195 mg
  • Each tablet contains: Sugar 1g
  • Do not exceed recommended dosage
  • Store at room temperature in a dry place
  • Do not use if clear neck seal is broken or missing

 

INACTIVE INGREDIENT

Acacia, Artificial Cherry Flavor, Artificial Red Berry Flavor, Colloidal Silica, D and C Red #27 Lake, FD and C Blue #1 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural and Artificial Spearmint Flavor, Strach, Sucrose

 

OTC - QUESTIONS

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

 

OTC - KEEP OUT OF REACH OF CHILDREN



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Plus PharmaCalcium Antacid Calcium Antacid


GENERIC: CALCIUM CARBONATE


DOSAGE: TABLET, CHEWABLE


ADMINSTRATION: ORAL


NDC: 61786-098-02


ACTIVE INGREDIENT(S):

  • CALCIUM CARBONATE 500mg in 1


INACTIVE INGREDIENT(S):

  • ACACIA
  • CELLULOSE, MICROCRYSTALLINE
  • MALTODEXTRIN
  • STARCH, CORN
  • MAGNESIUM STEARATE
  • D&C RED NO. 27
  • SILICON DIOXIDE
  • FD&C BLUE NO. 1
  • SUCROSE


COLOR: pink


FLAVOR: CHERRY


SHAPE: ROUND


SCORE: No score


SIZE: 16 mm


IMPRINT: GPI;1


PACKAGING: 30 in 1 BLISTER PACK




MM1

MM2

PLUS PHARMACALCIUM ANTACID  CALCIUM ANTACID
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-098
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION500 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorpinkScoreno score
ShapeROUND (TABLET, CHEWABLE) Size16mm
FlavorCHERRYImprint Code GPI;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-098-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product11/20/201402/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/20/201402/22/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2017
 
REMEDYREPACK INC.