FDA.reportPublic FDA data

Alka-Seltzer Heartburn ReliefChews Strawberry and Orange

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:19:56

Label at a glance#

ProductAlka-Seltzer Heartburn ReliefChews Strawberry and Orange
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Indications and uses

for the relief of: acid indigestion heartburn sour stomach upset stomach associated with these symptoms

Dosage and administration

adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor children under 12 years: consult a doctor do not take more than 10 chewable tablets in a 24-hour period

Storage and handling

each chewable tablet contains: calcium 300 mg store at room temperature. Avoid excessive heat above 40°C (104°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

for the relief of:

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if 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.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 10 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor
  • children under 12 years: consult a doctor
  • do not take more than 10 chewable tablets in a 24-hour period

Other information

STORAGE AND HANDLING SECTION

  • each chewable tablet contains: calcium 300 mg
  • store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, FD&C yellow #6, flavors, hydrogenated coconut oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propylene glycol, propyl paraben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, vegetable oil, white wax

Questions or comments?

OTC - QUESTIONS SECTION

1-800-986-0369
(Mon – Fri 9AM – 5PM EST) or www.alkaseltzer.com

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 6 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ON-THE-GO PACK

PEEL

strawberry & orange

Alka-

Seltzer ®

Calcium Carbonate /Antacid

EXTRA STRENGTH

HEARTBURN

RELIEFCHEWS ™

6 CHEWABLE

TABLETS

Label 6Label 6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN8
308915calcium carbonate 750 MG Chewable TabletSCD8
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY8

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0224-06Alka-Seltzer Heartburn ReliefChews Strawberry and Orange6 in 1 BLISTER PACKTABLET, CHEWABLE68
0280-0224-06Alka-Seltzer Heartburn ReliefChews Strawberry and Orange1 in 1 CARTONTABLET, CHEWABLE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0224-06EA - Each0280-022498e7ccd4-d1f8-4cc5-b1d2-0cb5449813c912018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
ACACIAINACTIVE INGREDIENT5C5403N26O1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6N1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OM1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SHELLACINACTIVE INGREDIENT46N107B71O1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
SORBITOLINACTIVE INGREDIENT506T60A25R1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
SUCROSEINACTIVE INGREDIENTC151H8M5541
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-02240280-0224-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ALUMINUM OXIDELMI26O6933IACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYLPARABENA2I8C7HI9TIACT
PHOSPHORIC ACIDE4GA8884NNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WHITE WAX7G1J5DA97FIACT
CALCIUM CARBONATEH0G9379FGKACTIB

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 5 · 286 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CORN SYRUPCORN SYRUP9G5L16BK6NTROCHE / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii+route
44 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, EXTENDED RELEASE / ORAL75.01 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii+route
40 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii+route
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route
40 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, DELAYED RELEASE / ORAL8 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route
24 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii+route
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii+route
44 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSUSPENSION, EXTENDED RELEASE / ORAL1500 mg/5mlExact identifier — unii+route
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, DELAYED RELEASE / ORAL230 mgExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii+route
40 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET / ORAL0.04 mgExact identifier — unii+route
10 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii+route
44 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, DELAYED RELEASE / ORAL0.08 mgExact identifier — unii+route
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, EXTENDED RELEASE / ORAL75.01 mgExact identifier — unii+route
24 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii+route
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, COATED / ORAL3 mgExact identifier — unii+route
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route
44 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route
40 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
Alka-Seltzer Heartburn ReliefChews Strawberry and OrangeCALCIUM CARBONATEBayer HealthCare LLC.8745ae49-e6d6-43d6-9530-bcdf0b6c90e52025-12-04WarningsExact identifier
ndc (package): 0280-0224-06
ndc (product): 0280-0224
ndc11 (package): 00280022406
spl id: 45265f01-4741-fd1f-e063-6294a90ad28f
spl set id: 8745ae49-e6d6-43d6-9530-bcdf0b6c90e5

Reported adverse events (FAERS/openFDA)#

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