MIRALAC ANTACID - calcium carbonate tablet 
North Safety Products

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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MIRALAC

Active ingredient (in each tablet)

Calcium carbonate 420 mg

Purpose

Antacid

Uses

for the relief of

Warnings

Enter section text here

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 interact with certain prescription drugs

Stop use and ask a doctor if

symptoms last for more than 2 weeks

ask a health professional before use

Keep this and all other drugs out of the reach of children

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

Directions

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

Other information

each tablet contains: calcium 168 mg

sucrose free

lactose free

store at room temperature

Inactive ingredients

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

Questions or comments?

1-800-430-4110

Principal Display Panel

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MIRALAC ANTACID 
calcium carbonate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0304
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 420 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color white (WHITE) Score 2 pieces
Shape ROUND Size 11mm
Flavor MINT (MINT FLAVOR) Imprint Code FR8
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0498-0304-91 5000 in 1 CARTON
1 NDC:0498-0304-90 2500 in 1 CARTON
1 NDC:0498-0304-50 250 in 1 CARTON
1 NDC:0498-0304-25 125 in 1 CARTON
1 NDC:0498-0304-10 50 in 1 CARTON
1 NDC:0498-0304-01 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 02/22/2013
Labeler - North Safety Products (019777263)
Establishment
Name Address ID/FEI Business Operations
North Safety Products 019777263 manufacture(0498-0304)
Establishment
Name Address ID/FEI Business Operations
UltraTab Laboratories 151051757 manufacture(0498-0304)

Revised: 7/2013
Document Id: 4675358c-7472-4184-a55f-ba8702142785
Set id: cac724a5-ffef-4ba2-823e-90897f8c7a84
Version: 1
Effective Time: 20130716
 
North Safety Products