MINT ANTACID- calcium carbonate tablet, chewable

MINT ANTACID by

Drug Labeling and Warnings

MINT ANTACID by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET- CALCIUM CARBONATE 420 MG

PURPOSE

ANTACID

INDICATIONS & USAGE

Uses:

for the relief of:

heartburn sour stomach acid indigestion

WARNINGS

Warnings:

Do not:

Take more than 18 tablets in a 24 hour period, or use the maximum dosage of

this product for more than 2 weeks, except under the advice of a physician.

Stop use and ask a doctor if:

You are currently taking any prescription drug. Antacids may react with certain

prescription drugs.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, 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.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 12 years of age and 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: Consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: acacia gum, flavor, magnesium stearate, maltodextrin, starch and sugar.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINT ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	420

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ACACIA (UNII: 5C5403N26O)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	ROUND	Size	12mm
Flavor	MINT	Imprint Code	FR8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-303-68	100 in 1 CARTON	04/07/2015
1	NDC: 67060-303-02	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	04/07/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-303)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-303)