FDA.reportPublic FDA data

Childrens Stomach Relief Antacid

Manufacturer
H E B | Guardian Drug Company
Effective date
2025-01-14
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:38

Label at a glance#

ProductChildrens Stomach Relief Antacid
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Dosage and administration

shake well before use find the right dose on the chart below based on weight (preferred), otherwise use age. repeat dose as needed dosing cup provided mL=milliliter Dosing Chart Weight (lbs.)  Age   Dose  under 24  under 2 yrs. ask a doctor   24-47  2-5 yrs.  5 mL  48-95  6-11 yrs.  10 mL

Storage and handling

each 5 mL contains:  calcium 161 mg store at controlled room temperature 20-25ºC (68ºF-77ºF)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 400 mg

PURPOSE

OTC - PURPOSE SECTION

Antacid

USE(S)

INDICATIONS & USAGE SECTION

relieves:

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

WARNINGS

WARNINGS SECTION

Do  not take more than 15 mL (age 2-5 yrs) or 30 mL (age 6-11 yrs) in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

symptoms lasts more than two weeks

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • find the right dose on the chart below based on weight (preferred), otherwise use age.
  • repeat dose as needed
  • dosing cup provided
  • mL=milliliter

Dosing Chart



Weight (lbs.) Age  Dose
 under 24 under 2 yrs.ask a doctor 
 24-47 2-5 yrs. 5 mL
 48-95 6-11 yrs. 10 mL


OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • each 5 mL contains: calcium 161 mg
  • store at controlled room temperature 20-25ºC (68ºF-77ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzyl alcohol, D&C yellow#10 dye, FD&C red#40 dye, flavors, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose, xanthagum.

Questions or comments?

SPL UNCLASSIFIED SECTION

1-(609) 860-2600 Mon.- Fri. 8:00 am - 4:30 pm.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Kid's pepto® active ingredient*
NDC 37808-638-03
H E B
Children's 
Stomach Relief
Calcium Carbonate 400 mg / 5 mL
Antacid
Relief of :


  • Acid Indigestion
  • Heartburn
  • Sour Stomach
  • Upset Stomach

Orange Creme Flavor 


4 FL OZ  (118 mL)

657-heb.jpg657-heb.jpg


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308901calcium carbonate 400 MG in 5 mL Oral SuspensionPSN2
308901calcium carbonate 80 MG/ML Oral SuspensionSCD2
308901calcium carbonate 400 MG per 5 ML Oral SuspensionSY2

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-638-03Childrens Stomach Relief Antacid118 mL in 1 BOTTLELIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-638CHILDRENS STOMACH RELIEF ANTACID (CALCIUM CARBONATE) LIQUID [H E B]2Current NDC, 1 package rows20250116_18fae1aa-1001-8035-e063-6394a90adc66.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-63837808-638-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
BENZYL ALCOHOLLKG8494WBHIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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 Stomach Relief AntacidCALCIUM CARBONATEH E B18fae1aa-1001-8035-e063-6394a90adc662025-01-14WarningsExact identifier
ndc (package): 37808-638-03
ndc (product): 37808-638
ndc11 (package): 37808063803
spl id: e6b41a8d-5bad-42bc-9de0-8262d04f170a
spl set id: 18fae1aa-1001-8035-e063-6394a90adc66

Reported adverse events (FAERS/openFDA)#

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