FDA.reportPublic FDA data

Alka-Seltzer Kids Tummy ReliefChews

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:02

Label at a glance#

ProductAlka-Seltzer Kids Tummy ReliefChews
Active ingredientCALCIUM CARBONATE, DIMETHICONE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients and purpoose

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each chewable tablet) Purpose
Calcium carbonate 750 mg….................................….…...Antacid
Simethicone 80 mg……………………………………….......Antigas

INDICATIONS & USAGE SECTION

Uses for the relief of:
● acid indigestion ● heartburn ● sour stomach
● upset stomach associated with these symptoms
● bloating, pressure, or stuffed feeling commonly referred to as gas

WARNINGS SECTION

Warnings

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.

OTC - WHEN USING SECTION

When using this product
● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period
● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period
● if pregnant, do not take more than 6 chewable tablets in 24 hours
● do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a
physician

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, inform your doctor that you are using this product.

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.
• do not take more than 6 chewable tablets in a 24-hour period
children 6 years to under 12 years• under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor.
• do not take more than 4 chewable tablets in a 24-hour period
children under 6 yearsconsult a doctor
  • if pregnant, do not take more than 6 chewable tablets in 24 hours

OTHER SAFETY INFORMATION

Other information
● each chewable tablet contains: calcium 300 mg
● store at room temperature. Avoid excessive heat above 40°C (104°F).
● close cap tightly after use

INACTIVE INGREDIENT SECTION

Inactive ingredients acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

Package label 28 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Works

Amazingly

Fast!

Alka-Seltzer® Kids

Tummy ReliefChews®

Calcium Carbonate/Antiacid

Simethicone/Antigas

•6 Symptom Relief•

•Upset Stomach

•Gas • Bloating

•Acid Indigestion

•Heartburn

•Upset Stomach

FRUIT PUNCH

28 CHEWABLE TABLETS

AS Tummy Relief ChewablesAS Tummy Relief Chewables

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1492387calcium carbonate 750 MG / simethicone 80 MG Chewable TabletPSN5
1492387calcium carbonate 750 MG / simethicone 80 MG Chewable TabletSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500592815GTIN-13: 0016500592815
EAN-13: 0016500592815
GTIN-12: 016500592815
UPC-A: 016500592815
GTIN storage (14 digits): 00016500592815		Label 2.8.21.jpg

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
0280-0051-01Alka-Seltzer Kids Tummy ReliefChews28 in 1 BOTTLE, PLASTICTABLET, CHEWABLE285

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00510280-0051-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
SORBITOL506T60A25RIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
WATER059QF0KO0RIACT
WHITE WAX7G1J5DA97FIACT
SHELLAC46N107B71OIACT
ACACIA5C5403N26OIACT
CALCIUM CARBONATEH0G9379FGKACTIB
CORN SYRUP9G5L16BK6NIACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
CARNAUBA WAXR12CBM0EIZIACT
DIMETHICONE92RU3N3Y1OACTIB
POTASSIUM HYDROXIDEWZH3C48M4TIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBIC ACIDX045WJ989BIACT

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
Alka-Seltzer Kids Tummy ReliefChewsCALCIUM CARBONATE AND DIMETHICONEBayer HealthCare LLC.ba48966e-3762-5fdf-e053-2995a90aeb3d2025-12-04WarningsExact identifier
ndc (package): 0280-0051-01
ndc (product): 0280-0051
ndc11 (package): 00280005101
spl id: 4525fb4f-fd84-0106-e063-6394a90a6ebd
spl set id: ba48966e-3762-5fdf-e053-2995a90aeb3d

Reported adverse events (FAERS/openFDA)#

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