FDA.reportPublic FDA data

Unishield Antacid

Manufacturer
Unishield | Unifirst First Aid Corporation | Prestige Packaging | Medique Products
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:13:01

Label at a glance#

ProductUnishield Antacid
Active ingredientCALCIUM CARBONATE
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Calcium Carbonate 420 mg

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses

relieves

■ acid indigestion

■ sour stomach

■ heartburn

■ upset stomach associated with these symptoms

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if

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

■ Have kidney disease

OTC - WHEN USING SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

I nactive ingredients

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

*may contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-480-5855

PACKAGE LABEL.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

Unishield Antacid Label 1Unishield Antacid Label 1

PACKAGE LABEL.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

Unishield Antacid Label 2Unishield Antacid Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN8
313884calcium carbonate 420 MG Chewable TabletSCD8
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49314-1023-32023-12-27C16284748780-10191ceaa-696f-198a-e063-dbdaa90aec3eUnishield Antacid
49314-1023-32023-07-28C16284748780-10191ceaa-696f-198a-e063-dbdaa90aec3eUnishield Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49314-1013-3Unishield Antacid50 in 1 BOXTABLET, CHEWABLE508
49314-1013-3Unishield Antacid2 in 1 PACKETTABLET, CHEWABLE28
49314-1023-3Unishield Antacid50 in 1 BOXTABLET, CHEWABLE508
49314-1023-3Unishield Antacid2 in 1 PACKETTABLET, CHEWABLE28

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49314-101349314-1013-3
49314-102349314-1023-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCROSEC151H8M554IACT
ACACIA5C5403N26OIACT
MINERAL OILT5L8T28FGPIACT
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM STEARATE70097M6I30IACT
SORBITOL506T60A25RIACT
MALTODEXTRIN7CVR7L4A2DIACT
ASPARTAMEZ0H242BBR1IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unishield AntacidCALCIUM CARBONATEUnishieldb5e4d635-4c15-a849-e053-2995a90ac5612025-09-08WarningsExact identifier
ndc (package): 49314-1013-3
ndc (package): 49314-1023-3
ndc (product): 49314-1023
ndc (product): 49314-1013
ndc11 (package): 49314101303
ndc11 (package): 49314102303
spl id: 3e4bfcc1-9e45-33d1-e063-6294a90abe0f
spl set id: b5e4d635-4c15-a849-e053-2995a90ac561

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.