CHILDRENS MYLICON ALL IN ONE TUMMY RELIEF FOR KIDS- antacid and antigas liquid

Childrens Mylicon All in One Tummy Relief for Kids by

Drug Labeling and Warnings

Childrens Mylicon All in One Tummy Relief for Kids by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 5 mL dose)

Calcium carbonate 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

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

Warnings

Ask a doctor or pharmacist before use if

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

Keep out of reach of children.

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

Directions

• 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

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

Inactive ingredients

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

Questions or comments?

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

Package/Label Principal Display Panel

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.

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.

INGREDIENTS AND APPEARANCE

CHILDRENS MYLICON ALL IN ONE TUMMY RELIEF FOR KIDS 
antacid and antigas liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-410
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-410-04	1 in 1 CARTON	11/24/2021
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	11/24/2021

Labeler - Infirst Healthcare Inc. (079159739)