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ANTACID by Kinray Inc.

Dosage form: tablet, chewable
Ingredients: CALCIUM CARBONATE 500mg
Labeler: Kinray Inc.
NDC Code: 61715-058

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.

Calcium Antacid Tablets

Active Ingredient

(in each chewable tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach

Warnings

Ask a doctor before use if you have

  • kidney stones
  • a calcium-restricted diet

    ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if symptoms last more than 2 weeks.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • chew 1-2 tablets as symptoms occurs.
  • do not take more than 8 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Other Information
  • each tablet contains: calcium 200 mg
  • store at room temperature

Inactive Ingredients

Al-lakes (D&C red #27, D&C yellow # 10, FD&C blue #1, FD&C yellow # 6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

Questions or Comments

Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate 500 mg

Antacid tablets

NDC: 61715-058-54 – 150 COUNT

ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-058
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
D&C RED NO. 27 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
CHERRY 
LEMON 
ORANGE 
Product Characteristics
ColorYELLOW, PINK, GREENScorescore with uneven pieces
ShapeROUNDSize16mm
FlavorLIME (Cherry,Lemon,Orange) Imprint CodeAP;043
Contains    
Packaging
#Item CodePackage Description
1NDC:61715-058-54150 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/28/2013
Labeler - Kinray Inc. (012574513)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(61715-058)

 
Kinray Inc.

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Medically reviewed on Jul 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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