TRIAL ANTACID - calcium carbonate tablet 
Zee Medical Inc

Disclaimer: Most OTC drugs are not reviewed and approved by 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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Drug Facts

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

Purpose-Antacid

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

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

If pregnant or breast-feeding baby, ask a health professional  
before use

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.

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

MM1Trial 250 Box 1

TRIAL ANTACID 
calcium carbonate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-310
Route of Administration ORAL DEA Schedule     
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
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
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)

Revised: 11/2012
Document Id: fd0f349b-9899-49c3-b740-3f77c661ce36
Set id: a17b9b76-b932-4147-99b1-d3b1f42f175d
Version: 1
Effective Time: 20121112
 
Zee Medical Inc