FDA.reportPublic FDA data

HIS ULC MINT BLUE

Manufacturer
SAMSUNG PHARM IND. CO., LTD.
Effective date
2013-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:06

Label at a glance#

ProductHIS ULC MINT BLUE
Active ingredientCalcium carbonate
Label structure8 sections

Indications and uses

adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime Taking a melt in your mouth and chew.

Dosage and administration

adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime Taking a melt in your mouth and chew.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Calcium carbonate 350mg

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:
Magnesium hydroxide, L-menthol, Aspartame, Sugar, Povidone, Lactose Hydrate, Spirulina color, Mint flavor, Calcium carboxymethylcellulose, Magnesium stearate

PURPOSE

OTC - PURPOSE SECTION

Effective for: Relieves:Heartburn, Sour stomach, Acid indigestion, Upset stomach associated with these symptoms

WARNINGS

WARNINGS SECTION

1. The following people must consult a doctor, dentist or pharmacist before administering the drug.
(1) Patients with kidney disorders
(2) Patients taking other drugs

2. Patients must immediately stop adminstration of the drug and consult a doctor, dentist or pharmacist if the following symptoms are observed. Carry these instructions when visiting.
(1) If symptoms of constipation or diarrhea occur while administering this drug
(2) When no improvement is detected after 2 weeks of administration

3. Other precautions when administering this drug
(1) Follow the given instructions and dosages
(2) When administering to children, it must be administered under the supervision of a parent or guardian

4. Storage directions
(1) Store in places out of the reach of children
(2) Keep away from direct sunlight and store sealed in cool places with low humidity.
(3) Do not store in different containers in order to prevent misuse and preserve quality (Only store in container if it has been specifically labelled and is not open to misuse)

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime
Taking a melt in your mouth and chew.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime
Taking a melt in your mouth and chew.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204637calcium carbonate 350 MG Chewable TabletPSN1
204637calcium carbonate 350 MG Chewable TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

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
49789-060-012019-11-27C16284748780-19855d018-d889-cd31-e053-dbdaa90ab51ad2b9e29f-7cc8-470b-9546-9614f8eda199

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49789-060-01HIS ULC MINT BLUE492 mg in 1 BLISTER PACKTABLET, CHEWABLE4921

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49789-060HIS ULC MINT BLUE (CALCIUM CARBONATE) TABLET, CHEWABLE [SAMSUNG PHARM IND. CO., LTD.]1Legacy NDC, 1 package rows20130403_d2b9e29f-7cc8-470b-9546-9614f8eda199.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Calcium carbonateACTIVE INGREDIENTH0G9379FGK1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
AspartameINACTIVE INGREDIENTZ0H242BBR11
magnesium hydroxideINACTIVE INGREDIENTNBZ3QY004S1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49789-06049789-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Calcium carbonateH0G9379FGKACTIB
magnesium hydroxideNBZ3QY004SIACT
AspartameZ0H242BBR1IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 25 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AspartameASPARTAMEZ0H242BBR1FILM, EXTENDED RELEASE / BUCCAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1SOLUTION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET / ORAL87 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1LOZENGE / ORAL136 mgExact identifier — unii candidate
19 equally ranked IID candidates
magnesium hydroxideMAGNESIUM HYDROXIDENBZ3QY004STABLET, FILM COATED / ORAL43.4 mgExact identifier — unii candidate
6 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1SUSPENSION / ORAL23 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1POWDER, FOR SOLUTION / ORAL233 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1GRANULE, EFFERVESCENT / ORAL30 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1GRANULE, FOR SUSPENSION / ORAL420 mgExact identifier — unii candidate
19 equally ranked IID candidates
magnesium hydroxideMAGNESIUM HYDROXIDENBZ3QY004STABLET, CHEWABLE / ORAL750 mgExact identifier — unii candidate
6 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1POWDER / ORAL63 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET / SUBLINGUAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1SYRUP / ORAL0.63 mg/5mlExact identifier — unii candidate
19 equally ranked IID candidates
magnesium hydroxideMAGNESIUM HYDROXIDENBZ3QY004SCAPSULE, DELAYED RELEASE / ORAL6.7 mgExact identifier — unii candidate
6 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1POWDER, FOR SUSPENSION / ORAL420 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, FOR SUSPENSION / ORAL15 mgExact identifier — unii candidate
19 equally ranked IID candidates
magnesium hydroxideMAGNESIUM HYDROXIDENBZ3QY004STABLET, DELAYED RELEASE / ORAL150 mgExact identifier — unii candidate
6 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1CAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
19 equally ranked IID candidates
magnesium hydroxideMAGNESIUM HYDROXIDENBZ3QY004STABLET / ORAL120 mgExact identifier — unii candidate
6 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL78 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, CHEWABLE / ORAL195 mgExact identifier — unii candidate
19 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING / ORAL180 mgExact identifier — unii candidate
19 equally ranked IID candidates
magnesium hydroxideMAGNESIUM HYDROXIDENBZ3QY004SPOWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
6 equally ranked IID candidates

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
b1cce823-c1c1-4653-8047-fbc087977c58d2b9e29f-7cc8-470b-9546-9614f8eda1992013-04-03WarningsExact identifier
spl id: b1cce823-c1c1-4653-8047-fbc087977c58
spl set id: d2b9e29f-7cc8-470b-9546-9614f8eda199

Reported adverse events (FAERS/openFDA)#

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