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NDC 49314-1023-03 Unishield Antacid 420 mg/1 Details

Unishield Antacid 420 mg/1

Unishield Antacid is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Unishield. The primary component is CALCIUM CARBONATE.

MedlinePlus Drug Summary

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 49314-1023-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Product Information

NDC	49314-1023
Product ID	49314-1023_de58259a-1ea0-7475-e053-2a95a90aba68
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Unishield Antacid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium Carbonate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	420
Active Ingredient Units	mg/1
Substance Name	CALCIUM CARBONATE
Labeler Name	Unishield
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2023-12-31

Package

Package Images

NDC 49314-1023-03 (49314102303)

Pricing Information	N/A
NDC Package Code	49314-1023-3
Billing NDC	49314102303
Package	50 PACKET in 1 BOX (49314-1023-3) / 2 TABLET, CHEWABLE in 1 PACKET
Marketing Start Date	2021-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5e4d635-4c15-a849-e053-2995a90ac561 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Calcium Carbonate 420 mg

SPL UNCLASSIFIED SECTION

Purpose

Antacid

SPL UNCLASSIFIED SECTION

Uses

relieves

■ acid indigestion

■ sour stomach

■ heartburn

■ upset stomach associated with these symptoms

SPL UNCLASSIFIED SECTION

Warnings

SPL UNCLASSIFIED SECTION

Do not use

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

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if

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

■ Have kidney disease

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of the reach of children.

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

I nactive ingredients

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

*may contain

SPL UNCLASSIFIED SECTION

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

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49314-1023-3	50 in 1 BOX	03/01/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	03/01/2021

UNISHIELD ANTACID

calcium carbonate tablet, chewable

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49314-1013-3	50 in 1 BOX	03/01/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	03/01/2021

Labeler - Unishield (790677053)

Registrant - Unifirst First Aid Corporation (832947092)

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

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

Revised: 5/2022

Document Id: de58259a-1ea0-7475-e053-2a95a90aba68

Set id: b5e4d635-4c15-a849-e053-2995a90ac561

Version: 5

Effective Time: 20220506

Search by Drug Name or NDC

NDC 49314-1023-03 Unishield Antacid 420 mg/1 Details

Unishield Antacid 420 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49314-1023-03 (49314102303)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b5e4d635-4c15-a849-e053-2995a90ac561 Details

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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