FDA.reportPublic FDA data

Soothe

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:52:09

Label at a glance#

ProductSoothe childrens
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Indications and uses

relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Dosage and administration

find the right dose on chart below based on weight (preferred); otherwise use age chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose as needed do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour period, or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor Dosing...

Storage and handling

each tablet contains: calcium 160 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 400 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves:

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

Warnings

WARNINGS SECTION

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 a doctor if

OTC - STOP USE SECTION

symptoms last more than two weeks.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • find the right dose on chart below based on weight (preferred); otherwise use age
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose as needed
  • do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour period, or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor

Dosing Chart

Weight (lb)Age (yr)Dose (chewable tablets)
under 24under 2ask a doctor
24-472-51 tablet
48-956-112 tablets

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 160 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sodium lauryl sulfate, sucrose, talc

Questions or comments?

OTC - QUESTIONS SECTION

 1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-5960-08

Walgreens

WALGREENS
PHARMACIST RECOMMENDED†

Compare to the active ingredient
in Pepto® Kids Chewables††

Children's 
Soothe®
CALCIUM CARBONATE 400 mg
CHEWABLE TABLETS / ANTACID

• Relieves heartburn, sour stomach &
acid indigestion

AGES
2-11
YEARS

24 CHEWABLE TABLETS

CHEW OR CRUSH TABLETS COMPLETELY
BEFORE SWALLOWING. DO NOT SWALLOW TABLETS WHOLE.

Bubble Gum
flavor

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
††This product is not manufactured or
distributed by The Procter & Gamble
Company, owner of the registered
trademark Pepto® Kids Chewables.
50844    REV1119A59608

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2021 Walgreen Co.

Walgreens 44-596A
Walgreens 44-596A

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317865calcium carbonate 400 MG (Ca 170 MG) Chewable TabletPSN16
317865calcium carbonate 400 MG Chewable TabletSCD16
317865calcium carbonate 400 MG (as calcium 161 MG) Chewable TabletSY16

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130311917124087GTIN-13: 0311917124087
EAN-13: 0311917124087
GTIN-12: 311917124087
UPC-A: 311917124087
GTIN storage (14 digits): 00311917124087		walgreens-44-596a-1.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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0363-5960-08Soothechildrens24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2416
0363-5960-08Soothechildrens1 in 1 CARTONTABLET, CHEWABLE116

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-59600363-5960-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ACACIA5C5403N26OIACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT

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
Soothe childrensCALCIUM CARBONATEWalgreen Company0235e083-5f3d-4bae-b14a-b12db623180c2026-03-31WarningsExact identifier
ndc (package): 0363-5960-08
ndc (product): 0363-5960
ndc11 (package): 00363596008
spl id: cd0bb2db-032c-4ab9-913f-23135b5add64
spl set id: 0235e083-5f3d-4bae-b14a-b12db623180c

Reported adverse events (FAERS/openFDA)#

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