FDA.reportPublic FDA data

Childrens Tummy Relief

Manufacturer
Genexa Inc.
Effective date
2025-02-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:15

Label at a glance#

ProductChildrens Tummy Relief
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Calcium carbonate USP 400 mg

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses

relieves

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - WHEN USING SECTION

When using this product

  • do not give the child more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in 24 hours
  • do not give the child the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Find right dose on chart below based on weight (preferable); otherwise use age

WeightAgeDose
over 48 lbs.6-11 yearschew 2 tablets as symptoms occur, not to exceed 6 tablets in 24 hours
24-47 lbs.2-5 yearschew 1 tablet as symptoms occur, not to exceed 3 tablets in 24 hours
under 24 lbs.under 2 yearsask a doctor

SPL UNCLASSIFIED SECTION

Other information

  • each tablet contains: elemental calcium 160 mg
  • store between 20-25°C (68-77°F) in a dry place out of direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic beet root, organic carnauba wax, dextose, organic flavors, organic maltodextrin, organic rice bran extract

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

Patent Pending I Distributed by:

Genexa Inc. Atlanta, GA 30318

genexa.com

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

R-20220321

NDC 69676-0060-7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 2-11

Tummy Relief

Calcium Carbonate Antacid

Heartburn

Sour Stomach

Acid Indigestion

Upset Stomach

Compare to active ingredient in Pepto Bismol® Kids

Chewable Tablets Bubblegum*

How we're different

Made without: talc, D&C red no. 27 aluminum lake, sorbitol & more!

Organic Berry & Vanilla Flavor

30 Chewable Tablets

23A_Tummy-Relief_Childrens_Carton_R-2022032123A_Tummy-Relief_Childrens_Carton_R-20220321

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317865calcium carbonate 400 MG (Ca 170 MG) Chewable TabletPSN2
317865calcium carbonate 400 MG Chewable TabletSCD2
317865calcium carbonate 400 MG (as calcium 161 MG) Chewable TabletSY2

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0060-72025-02-26C16284748780-12cef2736-6474-d83d-e063-dadaa90ab31fChildren's Tummy Relief
69676-0060-72025-01-30C16284748780-12cef2736-6474-d83d-e063-dadaa90ab31fChildren's Tummy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0060-7Childrens Tummy Relief30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE302
69676-0060-7Childrens Tummy Relief1 in 1 CARTONTABLET, CHEWABLE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0060CHILDRENS TUMMY RELIEF (CALCIUM CARBONATE) TABLET, CHEWABLE [GENEXA INC.]2Current NDC, 2 package rows20250228_f4d39d3e-82d0-2673-e053-2995a90a7d2a.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-006069676-0060-7

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
BEETN487KM8COKIACT
CARNAUBA WAXR12CBM0EIZIACT
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
RICE BRANR60QEP13ICIACT
CALCIUM CARBONATEH0G9379FGKACTIB

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
Childrens Tummy ReliefCALCIUM CARBONATEGenexa Inc.f4d39d3e-82d0-2673-e053-2995a90a7d2a2025-02-20WarningsExact identifier
ndc (package): 69676-0060-7
ndc (product): 69676-0060
ndc11 (package): 69676006007
spl id: 2ea06eb3-9f46-7640-e063-6294a90af29c
spl set id: f4d39d3e-82d0-2673-e053-2995a90a7d2a

Reported adverse events (FAERS/openFDA)#

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