TRIAL ANTACID- calcium carbonate tablet

Trial Antacid by

Drug Labeling and Warnings

Trial Antacid by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultra Seal Corporation, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet)  Calcium Carbonate-420 mg

PURPOSE

Purpose-Antacid

INDICATIONS & USAGE

Uses relieves:
■ heartburn
■ acid indigestion
■ sour stomach
■ upset stomach due to these symptoms

DOSAGE & ADMINISTRATION

Directions

• chew 2 to 4 tablets. Repeat hourly if symptoms return.
• do not take more than 18 tablets in 24 hours
• do not use the maximum dosage more than 2 weeks

WARNINGS

Warnings
Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interfere
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.

INACTIVE INGREDIENT

nactive ingredients
acacia*, cornstarch*, magnesium stearate, silica*, sorbitol, mint flavor, stearic acid* *contains one or more of these ingredients

PRINCIPAL DISPLAY PANEL

MM11

INGREDIENTS AND APPEARANCE

TRIAL ANTACID 
calcium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-310
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 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
ACACIA (UNII: 5C5403N26O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (ZEE;TL)	Size	13mm
Flavor	SPEARMINT (spearmint)	Imprint Code	ZEE;TL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35418-310-69	500 in 1 CARTON	06/12/2012
1	NDC: 35418-310-68	50 in 1 CARTON
1	NDC: 35418-310-67	125 in 1 CARTON
1	NDC: 35418-310-02	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	06/12/2012

Labeler - Zee Medical Inc (009645623)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(35418-310)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	repack(35418-310)