Childrens Mylicon All in One Tummy Relief for Kids

Manufacturer
Infirst Healthcare Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:57

Label at a glance#

ProductChildrens Mylicon All in One 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

shake well before use measure with dosing cup provided follow directions based on age/weight below or as directed by a doctor repeat as needed do not use the maximum dosage for more than two weeks except under the advice and supervision of a doctor clean dosing cup after use mL = milliliter Age Weight Dosage (mL) under 2 yrs under 24 lbs ask a doctor 2-5 yrs 24-47 lbs 5 mL. Not more than 15 mL in 24 hours. 6-11 yr...

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 400 mg

Simethicone 40 mg

Purpose

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

  • shake well before use
  • measure with dosing cup provided
  • follow directions based on age/weight below or as directed by a doctor
  • repeat as needed
  • do not use the maximum dosage for more than two weeks except under the advice and supervision of a doctor
  • clean dosing cup after use
  • mL = milliliter

Age

Weight

Dosage (mL)

under 2 yrs

under 24 lbs

ask a doctor

2-5 yrs

24-47 lbs

5 mL. Not more than 15 mL in 24 hours.

6-11 yrs

48-95 lbs

10 mL. Not more than 30 mL in 24 hours.

Other information

SPL UNCLASSIFIED SECTION

  • each 5 mL dose contains:calcium 160 mg, sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carboxymethylcellulose sodium, D&C red 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mylicon 4 oz Carton
Mylicon 4 oz Carton

FROM THE MAKERS OF THE #1 PEDIATRICIAN RECOMMENDED INFANT GAS BRAND

new!

Children’s MYLICON ®

Antacid/Antigas

All-in-One Tummy Relief for Kids

Multi-symptom relief of upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating.

Bubble Gum Flavor

4 FL OZ (120 mL)          24 Doses
                                        Ages 2-11

Important:Keep this carton for future reference on full labeling

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

New great-tasting Children’s Mylicon All-in-One Tummy Relief liquid works on contact to quickly soothe upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating.

Children’s Mylicon All-in-One Tummy Relief is a multi-purpose solution to help treat more causes of tummy aches and discomfort..

Children’s Mylicon combines the antigas medicine pediatricians recommend most with a soothing antacid for more complete, all-in-one relief for kids ages 2-11.

Gluten Free

No Saccharin

No Botanicals

Please visit us @ mylicon.com

Manufactured for: Infirst Healthcare Inc., Westport, CT 06880

©2021 Infirst Healthcare Inc.

Mylicon 4 oz label
Mylicon 4 oz label

Children’s MYLICON ®

Antacid/Antigas

All-in-One Tummy Relief for Kids

Multi-symptom relief of upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating.

Bubble Gum Flavor

Ages 2-11

4 FL OZ (120 mL)

New great-tasting Children’s Mylicon All-in-One Tummy Relief liquid works on contact to quickly soothe upset tummies due to bloating, gas, and discomfort from acid indigestion and overeating.

Children’s Mylicon combines the antigas medicine pediatricians recommend most with a soothing antacid for more complete, all-in-one relief for kids ages 2-11.

Gluten Free

No Saccharin or Botanicals

SEE CARTON FOR FULL LABELING

Please visit us @ mylicon.com

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2021 Infirst Healthcare Inc.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2599608calcium carbonate 80 MG/mL / simethicone 8 MG/mL Oral SuspensionPSN2
2599612MYLICON Children's 400 MG / 40 MG in 5 mL Oral SuspensionPSN2
2599612calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral Suspension [Mylicon Children's]SBD2
2599608calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD2
2599612Mylicon Children's (calcium carbonate 400 MG / simethicone 40 MG per 5 ML) Oral SuspensionSY2

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
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
62372-410-04Childrens Mylicon All in One Tummy Relief for Kids120 mL in 1 BOTTLELIQUID1202
62372-410-04Childrens Mylicon All in One Tummy Relief for Kids1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-410CHILDRENS MYLICON ALL IN ONE TUMMY RELIEF FOR KIDS (ANTACID AND ANTIGAS) LIQUID [INFIRST HEALTHCARE INC.]2Current NDC, Legacy NDC, 2 package rows20240111_0952eba8-6de2-4a77-956d-339fab437472.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
62372-41062372-410-04

Ingredients#

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

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

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 All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
ndc (package): 62372-410-04
ndc (product): 62372-410
ndc11 (package): 62372041004
spl id: 0bb08753-8604-dcd1-e063-6294a90a4bd1
spl set id: 0952eba8-6de2-4a77-956d-339fab437472

Reported adverse events (FAERS/openFDA)#

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