MIRALAC- calcium carbonate tablet 
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-0303: Miralac

Active ingredient (in each chewable tablet)

Calcium carbonate 420 mg

Purpose

Antacid

Uses

for the relief of

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

Warnings


Ask a doctor before use if you have

  • kidney stones
  • calcium-restricted diet

Ask a doctor before use if you are

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

When using this product

do not take more than 12 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.

Keep out of the reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

chew 1 to 2 tablets every 4 hours as symptoms occur, or as directed by a doctor.

Other information

  • each tablet contains: calcium 170 mg
  • sucrose free
  • lactose free
  • store at room temperature
  • TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN





Inactive ingredients

magnesium stearate, mint flavor, silicon dioxide, sorbitol, starch

Questions or comments?

1-800-430-5490

Principal Display Panel

Miralac

MIRALAC 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (White) Score2 pieces
ShapeROUNDSize11mm
FlavorMINT (Mint Flavor) Imprint Code FR8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0303-10100 in 1 BOX, UNIT-DOSE02/22/2012
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-0303-25250 in 1 BOX, UNIT-DOSE02/22/2012
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0498-0303-50500 in 1 BOX, UNIT-DOSE02/22/2012
32 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/22/201212/29/2022
Labeler - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
Document Id: 0eca21e1-7b54-7974-e063-6294a90ac4b8
Set id: 7ccb324f-b12b-4867-87d5-b444e0c5b9a5
Version: 14
Effective Time: 20240112
 
Honeywell Safety Products USA, Inc