Trial Antacid: Package Insert and Label Information

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.

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

MM1

Trial 250 Box
(click image for full-size original)

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 (CARBONATE ION) CALCIUM CARBONATE 420 mg
Inactive Ingredients
Ingredient Name Strength
SORBITOL
ACACIA
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
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 Multilevel Packaging
1 NDC:35418-310-69 500 CARTON in 1 CARTON contains a CARTON (35418-310-68)
1 NDC:35418-310-68 50 CARTON in 1 CARTON This package is contained within the CARTON (35418-310-69) and contains a CARTON (35418-310-67)
1 NDC:35418-310-67 125 PACKET in 1 CARTON This package is contained within the CARTON (35418-310-68) and contains a PACKET (35418-310-02)
1 NDC:35418-310-02 2 TABLET in 1 PACKET This package is contained within a CARTON (35418-310-67) and a CARTON (35418-310-68) and a CARTON (35418-310-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 06/12/2012 06/01/2023
Labeler — Zee Medical Inc (009645623)
Establishment
Name Address ID/FEI Operations
Ultratab Laboratories, Inc. 151051757 manufacture (35418-310)

Revised: 01/2023 Zee Medical Inc

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