FDA.reportPublic FDA data

Genexa Kids Tummy Relief

Manufacturer
PNP Pharmaceuticals Inc.
Effective date
2026-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:41:45

Label at a glance#

ProductKids Tummy Relief
Active ingredientCALCIUM CARBONATE
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 400mg

OTC - PURPOSE SECTION

Antacid

INDICATIONS & USAGE SECTION

Relieves:

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

WARNINGS 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

  • 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

DirectionsDirections

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

carnauba wax (non-GMO), dextrose (natural), flavors (organic), maltodextrin, starch (natural)

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

Do not use if seal under the cap is disturbed or missing

Distributed by: Genexa Inc.,

Atlanta, GA 30324

genexa.com

NDC 69676-0103-7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84998-010384998-0103-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSEIY9XDZ35W2IACT
STARCH, POTATO8I089SAH3TIACT
CARNAUBA WAXR12CBM0EIZIACT
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
Kids Tummy ReliefCALCIUM CARBONATEPNP Pharmaceuticals Inc.5103a317-5c4a-ec96-e063-6294a90aad7e2026-07-01WarningsExact identifier
ndc (package): 84998-0103-7
ndc (product): 84998-0103
ndc11 (package): 84998010307
spl id: 5103a317-5c4b-ec96-e063-6294a90aad7e
spl set id: 5103a317-5c4a-ec96-e063-6294a90aad7e

Reported adverse events (FAERS/openFDA)#

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