POLARIS MINT ANTACID- calcium carbonate tablet, chewable

POLARIS MINT ANTACID by

Drug Labeling and Warnings

POLARIS MINT ANTACID by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, Ultraseal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

UseS

For the relief of-Sour Stomach, Upset Stomach, Heartburn, Acid Indigestion

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health

professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. In

case of overdose, get medical help or

contact a Poison Control Center right

away.

Prompt medical attention is critical for adults as

well as for children, even if you do not notice any signs

or symptoms.

WARNINGS

Warnings:

Ask a doctor or health professional before use if you are:

currently taking a prescription drug. Antacids may react

with certain prescription drugs.

DOSAGE & ADMINISTRATION

Directions:Do not use more thsn directed.  Adults and children 12 years or older.

Take 2 tablets every 4 to 6 hours or as needed,

do not exceed 18 tablets in 24 hours, or as

directed by a doctor. 

Children under 12 years-Do not give to children under 12 years unless directed by a doctor.

INACTIVE INGREDIENT

Inactive Ingredients:

corn startch, D&C Yellow #10,

FD&C Blue #1, flavor,

magnesium stearate,

silicon dioxide, startch,

sucrose

ACTIVE INGREDIENT

ACTIVE INGREDIENT-calcium carbonate 420 MG

PURPOSE

ANTACID

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POLARIS MINT ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-2552
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	420 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (WHITE WITH GREEN FLECKS)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-2552-5	250 in 1 CARTON	04/03/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69103-2552-6	100 in 1 CARTON	04/03/2015
2		2 in 1 PACKET; 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	03/31/2015

Labeler - Provision Medical Products (036936831)

Registrant - Provision Medical Products (036936831)

Establishment
Name	Address	ID/FEI	Business Operations
Ultraseal Corporation		085752004	pack(69103-2552)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(69103-2552)