UNISHIELD ANTACID- calcium carbonate tablet, chewable

Unishield Antacid by

Drug Labeling and Warnings

Unishield Antacid by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation, Prestige Packaging, Medique Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Calcium Carbonate 420 mg

PURPOSE

Purpose

Antacid

INDICATIONS & USAGE

Uses

relieves

■ acid indigestion

■ sour stomach

■ heartburn

■ upset stomach associated with these symptoms

WARNINGS

Warnings

DO NOT USE

Do not use

■ the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if

■ are taking a prescription drug. Antacids may interact with certain prescription drugs.

■ Have kidney disease

WHEN USING

When using this product

■ do not take more than 19 tablets in a 24 hour period. If symptoms persist for more than 2 weeks, stop using this product and see a doctor.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

DOSAGE & ADMINISTRATION

Directions

Adults and children: (12 years and older) Chew 2 tablets every 2 - 3 hours as symptoms occur, repeat hourly if needed. Do not exceed 19 tablets in 24 hours.

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

■calcium content per tablet: 168 mg

■ phenylketonurics: each tablet may contain 1.5 mg phenylalanine

■ store at room temperature 59º-86ºF (15º-30ºC) in a dry place

■ tamper-evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT

I nactive ingredients

aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*

*may contain

QUESTIONS

Questions or comments? 1-800-480-5855

PRINCIPAL DISPLAY PANEL

Unishield

Antacid

Calcium Carbonate 420 mg

100 Tablets/2 Tablets Per Packet

Calcium Rich Chewable Tablets

Pull To Open

Relieves upset stomach, and indigestion
and heartburn

Compare active ingredient to: TUMS®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

PRINCIPAL DISPLAY PANEL

Unishield

Antacid

Calcium Carbonate 420 mg

100 Tablets/2 Tablets Per Packet

Calcium Rich Chewable Tablets

Pull To Open

Relieves upset stomach, and indigestion
and heartburn

Compare active ingredient to: TUMS®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

UNISHIELD ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-1023
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	420 mg

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor	MINT (Peppermint)	Imprint Code	FR;8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-1023-3	50 in 1 BOX	03/01/2021
1		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 Drug	M001	03/01/2021	12/24/2023

UNISHIELD ANTACID 
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-1013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	420 mg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SORBITOL (UNII: 506T60A25R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;036
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-1013-3	50 in 1 BOX	03/01/2021
1		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 Drug	M001	03/01/2021

Labeler - Unishield (790677053)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(49314-1013, 49314-1023)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	pack(49314-1013, 49314-1023)