FDA.reportPublic FDA data

Alka Seltzer

Manufacturer
BestCo Inc. | Bayer
Effective date
2016-02-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:59

Label at a glance#

ProductAlka Seltzer
Active ingredientCALCIUM CARBONATE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses for the relief of:

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

WARNINGS SECTION

Warnings

Do not useif you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

  • do not take more than 5 chewable tablets in a 24-hour period
  • do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
  • constipation may occur

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor
  • children under 12 years: consult a doctor
  • do not take more than 5 chewable tablets in a 24-hour period

OTHER SAFETY INFORMATION

Other information

  • each chewable tablet contains: calcium 300 mg
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive
  • store at room temperature. Avoid humidity.
  • close cap tightly after use.

INACTIVE INGREDIENT SECTION

Inactive ingredients

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax

OTC - QUESTIONS SECTION

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM-5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka Seltzer HB 90 ctAlka Seltzer HB 90 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN1
308915calcium carbonate 750 MG Chewable TabletSCD1
308915calcium carbonate 750 MG (calcium 300 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
52642-226-902020-01-31C16284748780-19d75b9d0-0745-f424-e053-dadaa90a57ceCalcium carbonate 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52642-226-90Alka Seltzer90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52642-226ALKA SELTZER (CALCIUM CARBONATE) TABLET, CHEWABLE [BESTCO INC.]1Legacy NDC, 1 package rows20160215_2b95d0b8-a30a-667d-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52642-22652642-226-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
WATER059QF0KO0RIACT

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
2b95d0b8-a30b-667d-e054-00144ff8d46c2b95d0b8-a30a-667d-e054-00144ff8d46c2016-02-12WarningsExact identifier
spl id: 2b95d0b8-a30b-667d-e054-00144ff8d46c
spl set id: 2b95d0b8-a30a-667d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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