Label: MIRALAC ANTACID - calcium carbonate tablet
view more0498-0304-90, 0498-0304-91
- Packager: North Safety Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient (in each tablet)
Calcium carbonate 420 mgClose
for the relief of
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
Enter section text here
Ask a doctor before use if
you are presently taking a prescription drug. Antacids may interact with certain prescription drugs
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.
take 1 to 2 tablets every 4 hours as symptoms occur or as directed by a doctor.Close
- Other information
each tablet contains: calcium 168 mg
store at room temperatureClose
- Inactive ingredients
magnesium stearate, mint flavor, silicon dioxide, sorbitol, starchClose
- Questions or comments?
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
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)