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Extra Strength Antacid by PuraCap Pharmaceutical LLC

Dosage form: tablet, chewable
Ingredients: CALCIUM CARBONATE 750mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-323

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.

Extra Strength Antacid Tablets

Active ingredient (per tablet)

Calcium Carbonate USP 750 mg

Purpose

Antacid

Uses

relieves

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

Warnings

Ask a doctor or pharmacist before use if you are

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

When using this product
  • do not take more than 10 tablets in 24 hours
  • if pregnant do not take more than 6 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Keep out of reach of children.

Directions
  • adults and children 12 years of age and over: chew 2 - 4 tablets as symptoms occur, or as directed by a doctor
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information
  • each tablet contains: calcium 300 mg
  • store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

dextrose, flavor (peppermint), maltodextrin, magnesium stearate

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Extra Strength Antacid Tablets

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC 51013-323-54

EXTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-323
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION750 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
PEPPERMINT 
MALTODEXTRIN 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint CodeAP;052
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-323-5415 POUCH in 1 CARTON
12 TABLET, CHEWABLE in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/13/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063manufacture(51013-323)

Revised: 12/2017
 
PuraCap Pharmaceutical LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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