MIRALAC- calcium carbonate tablet

Miralac by

Drug Labeling and Warnings

Miralac by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MIRALAC 
calcium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0303
Route of Administration	ORAL

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: 0498-0303-10	100 in 1 BOX, UNIT-DOSE	02/22/2012
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-0303-25	250 in 1 BOX, UNIT-DOSE	02/22/2012
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-0303-50	500 in 1 BOX, UNIT-DOSE	02/22/2012
3		2 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/22/2012

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-0303)