FDA.reportPublic FDA data

NUTRALOX

Manufacturer
A-S Medication Solutions
Effective date
2019-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:21

Label at a glance#

ProductNUTRALOX
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Dosage and administration

Do not take more than directed Adults and children 12 years of age and over: thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur do not take more than 16 tablets in 24 hours unless directed by a doctor do not use the maximum dose for more than 2 weeks Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet): Calcium Carbonate 420 mg

OTC - PURPOSE SECTION

Purpose: Antacid

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interfere with certain prescription drugs.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms last for more than 2 weeks

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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions:

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed

Adults and children 12 years of age and over:

  • thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur
  • do not take more than 16 tablets in 24 hours unless directed by a doctor
  • do not use the maximum dose for more than 2 weeks

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Acacia Gum, Flavor, Magnesium Stearate, Maltodextrin, Silicon Dioxide, Starch, Sucrose

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4612

NDC: 50090-4612-0 2 TABLET, CHEWABLE in a PACKET / 50 in a BOX, UNIT-DOSE

CALCIUM CARBONATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN1
1358869Nutralox 420 MG Chewable TabletPSN1
1358869calcium carbonate 420 MG Chewable Tablet [Nutralox]SBD1
313884calcium carbonate 420 MG Chewable TabletSCD1
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY1
1358869Nutralox 420 MG Chewable TabletSY1

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
50090-4612-02023-01-30C16284748780-1f386c64a-169b-0266-e053-dadaa90a7c1aNUTRALOX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4612-0NUTRALOX2 in 1 PACKETTABLET, CHEWABLE21
50090-4612-0NUTRALOX50 in 1 BOX, UNIT-DOSETABLET, CHEWABLE501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4612NUTRALOX (CALCIUM CARBONATE) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20191031_5c5e1095-2a23-41a7-bdda-d286e0c2250e.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-461250090-4612-0
50332-0106

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM STEARATE70097M6I30IACT
SUCROSEC151H8M554IACT
ACACIA5C5403N26OIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
c5409ea1-f52b-46f3-8d22-1330b2498a825c5e1095-2a23-41a7-bdda-d286e0c2250e2019-10-30WarningsExact identifier
spl id: c5409ea1-f52b-46f3-8d22-1330b2498a82
spl set id: 5c5e1095-2a23-41a7-bdda-d286e0c2250e

Reported adverse events (FAERS/openFDA)#

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