PLUS PHARMA CALCIUM ANTACID- calcium carbonate tablet, chewable 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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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Calcium Antacid

Active ingredient (in each tablet)

Calcium Carbonate, USP 500 mg


Purpose

Antacid


Uses

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.


Ask a doctor or pharmacist before use if you are

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

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of reach of children.

Directions

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

Other information

  • 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 ingredients

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


Questions?

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


Principal Display Panel

PlusPHARMA

CALCIUM ANTACID

500 mg

Antacid


  • Regular Strength
  • Assorted Flavors

*Compare to the Active Ingredient in Tums® Regular Strength

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Tums®.

150 CHEWABLE TABLETS 500 mg each



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PLUS PHARMA  CALCIUM ANTACID
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-735
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colorpink (cherry flavor) , white (spearmint flavor) , blue (grape flavor) Scoreno score
ShapeROUND (flat faced beveled edge uncoated) Size16mm
FlavorCHERRY (pink tablet) , SPEARMINT (white tablet) , GRAPE (blue tablet) Imprint Code GPI;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-735-15150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/200603/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/27/200603/31/2022
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270manufacture(51645-735)

Revised: 12/2019
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma