FDA.reportPublic FDA data

First Aid Only Antacid Tablets

Manufacturer
Acme United Corporation
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:39:18

Label at a glance#

ProductFirst Aid Only Antacid
Active ingredientCALCIUM CARBONATE
Label structure10 sections

Indications and uses

For the relief of the following symptoms associated with acid indigestion sour stomach heartburn upset stomach associated with these symptoms

Dosage and administration

do not use more than directed Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 420 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

For the relief of the following symptoms associated with

  • acid indigestion
  • sour stomach
  • heartburn
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or phamacist before use if you are

OTC - ASK DOCTOR SECTION

  • taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 19 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advise and supervision of a physician
  • do not exceed recommended dosage

Stop using this product and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last more than 2 weeks

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or breast feeding,

ask a health profdessional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed

SPL UNCLASSIFIED SECTION

Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 tablets in 24 hours.

SPL UNCLASSIFIED SECTION

Children under 12 years: Do not give to children under 12 years of age.

Other information

SPL UNCLASSIFIED SECTION

  • Phenylketonurics: contains phenylalanine 1.5 mg per tablet
  • each tablet contains 168 mg of elemental calcium
  • store at room temperature 59-86°F (15-30°C) in a dry place
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

*may contain

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-835-2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Only Antacid Label

First Aid Only Antacid LabelFirst Aid Only Antacid Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN2
313884calcium carbonate 420 MG Chewable TabletSCD2
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-0287-01First Aid Only Antacid2 in 1 PACKETTABLET, CHEWABLE22
0924-0287-01First Aid Only Antacid20 in 1 BOX, UNIT-DOSETABLET, CHEWABLE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0287FIRST AID ONLY ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241127_68902dda-a13c-ff2e-e053-2991aa0a06b1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-02870924-0287-01
47682-201

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique AlcalakCALCIUM CARBONATEUnifirst First Aid Corporation60703e3d-52b1-49c4-b4e2-59d96fa09a782025-09-08WarningsExact identifier
ndc (product): 47682-201
First Aid Only AntacidCALCIUM CARBONATEAcme United Corporation68902dda-a13c-ff2e-e053-2991aa0a06b12024-11-26WarningsExact identifier
ndc (package): 0924-0287-01
ndc (product): 0924-0287
ndc11 (package): 00924028701
spl id: 27d7f92d-3970-a964-e063-6394a90a9650
spl set id: 68902dda-a13c-ff2e-e053-2991aa0a06b1

Reported adverse events (FAERS/openFDA)#

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