FDA.reportPublic FDA data

Childrens Mylicon Tummy Relief for Kids

Manufacturer
Infirst Healthcare Inc.
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:55

Label at a glance#

ProductChildrens Mylicon Tummy Relief for Kids
Active ingredientCALCIUM CARBONATE, DIMETHICONE
Label structure9 sections

Indications and uses

relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms pressure and bloating commonly referred to as gas overindulgence in food and drink

Dosage and administration

follow directions based on age/weight below repeat as needed do not use the maximum dosage for more than two weeks except under the advice and supervision of a doctor Weight Age Dosage under 24 lbs under 2 yrs ask a doctor 24-47 lbs 2-5 yrs 1 tablet, Not more than 3 tablets in 24 hours 48-95 lbs 6-11 yrs 2 tablets, Not more than 6 tablets in 24 hours

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 400 mg

Simethicone 40 mg

Purposes

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating commonly referred to as gas
  • overindulgence in food and drink

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

your child is presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • follow directions based on age/weight below
  • repeat as needed
  • do not use the maximum dosage for more than two weeks except under the advice and supervision of a doctor

Weight

Age

Dosage

under 24 lbs

under 2 yrs

ask a doctor

24-47 lbs

2-5 yrs

1 tablet, Not more than 3 tablets in 24 hours

48-95 lbs

6-11 yrs

2 tablets, Not more than 6 tablets in 24 hours

Other information

SPL UNCLASSIFIED SECTION

  • e ach chewable tablet contains:calcium 160 mg
  • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, crospovidone, D&C red 27, dextrose, flavors, magnesium stearate, maltodextrin, sucralose,

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-848-3284 (English & Spanish)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's Mylicon Tummy Relief for KidsChildren's Mylicon Tummy Relief for Kids

Great tasting Chewable Tablets!

  • New!

Children’s MYLICON ®Antacid/ Antigas

Tummy Relief for Kids

Works quickly to soothe upset tummies

due to bloating, gas and discomfort

from acid indigestion and overeating

  • Multi- Symptom Relief for Upset Tummies
  • Multi-Symptom Tummy Relief for Kids

Cherry Flavor!

24 CHEWABLE TABLETS Ages 2 to 11

Important: Keep this carton for future reference on full labeling.

Visit us at Mylicon.com

Manufactured for:

Infirst Healthcare Inc,

Westport, CT 06880

©2018 Infirst Healthcare Inc.

Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co,

TAMPER EVIDENT: do not use if imprinted safety seal under cap is broken or missing.

Children Mylicon Pouch Pack

SPL UNCLASSIFIED SECTION

Children Mylicon Tummy Relief
Children Mylicon Tummy Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1999195calcium carbonate 400 MG / simethicone 40 MG Chewable TabletPSN4
1999202MYLICON Children's 400 MG/ 40 MG Chewable TabletPSN4
1999202calcium carbonate 400 MG / simethicone 40 MG Chewable Tablet [Mylicon Children's]SBD4
1999195calcium carbonate 400 MG / simethicone 40 MG Chewable TabletSCD4
1999202Mylicon Children's (calcium Carbonate 400 MG / simethicone 40 MG) Chewable TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

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
62372-400-02Childrens Mylicon Tummy Relief for Kids2 in 1 POUCHTABLET, CHEWABLE24
62372-400-24Childrens Mylicon Tummy Relief for Kids24 in 1 BOTTLE, PLASTICTABLET, CHEWABLE244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-400CHILDRENS MYLICON TUMMY RELIEF FOR KIDS (ANTACID AND ANTIGAS) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]4Current NDC, Legacy NDC, 2 package rows20231220_432d5b4c-a69b-45f9-b7f0-216726a3eead.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62372-400-24EA - Each62372-400d5a6d676-0133-4d85-9de8-4d70a2e8e03f12022-06-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-40062372-400-24, 62372-400-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
D&C RED NO. 272LRS185U6KIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT
CALCIUM CARBONATEH0G9379FGKACTIB
DIMETHICONE92RU3N3Y1OACTIB

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 Mylicon Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.432d5b4c-a69b-45f9-b7f0-216726a3eead2023-12-01WarningsExact identifier
ndc (package): 62372-400-02
ndc (package): 62372-400-24
ndc (product): 62372-400
ndc11 (package): 62372040002
ndc11 (package): 62372040024
spl id: 0b79a8a8-a1ba-7326-e063-6294a90add63
spl set id: 432d5b4c-a69b-45f9-b7f0-216726a3eead

Reported adverse events (FAERS/openFDA)#

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