Your browser does not support JavaScript! MIRALAC ANTACID (CALCIUM CARBONATE) TABLET [NORTH SAFETY PRODUCTS]
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RxNorm Names

MIRALAC ANTACID (calcium carbonate) tablet
[North Safety Products]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each tablet)

Calcium carbonate 420 mg

Purpose

Antacid

Uses

for the relief of

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

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

image of pdpMM1

MIRALAC ANTACID 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0498-0304
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE420 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SORBITOL 
STARCH, CORN 
Product Characteristics
Colorwhite (WHITE) Score2 pieces
ShapeROUNDSize11mm
FlavorMINT (MINT FLAVOR) Imprint Code FR8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0304-915000 in 1 CARTON
1NDC:0498-0304-902500 in 1 CARTON
1NDC:0498-0304-50250 in 1 CARTON
1NDC:0498-0304-25125 in 1 CARTON
1NDC:0498-0304-1050 in 1 CARTON
1NDC:0498-0304-012 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/22/2013
Labeler - North Safety Products (019777263)
Establishment
NameAddressID/FEIBusiness Operations
North Safety Products019777263manufacture(0498-0304)
Establishment
NameAddressID/FEIBusiness Operations
UltraTab Laboratories151051757manufacture(0498-0304)

Revised: 7/2013
 
North Safety Products

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