Active Ingredients (In Each Tablet)
Calcium carbonate 400 mg
Simethicone 40 mg
Childrens Mylicon Tummy Relief For Kids Tablet, Chewable
FDA Label NDC 62372-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Infirst Healthcare Inc. for the product Childrens Mylicon Tummy Relief For Kids (NDC 62372-400). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each tablet), purposes, uses, ask a doctor or pharmacist before use if, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
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
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
- 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
- each chewable tablet contains: calcium 160 mg
- store between 20-25°C (68-77°F)
Inactive Ingredients
adipic acid, crospovidone, D&C red 27, dextrose, flavors, magnesium stearate, maltodextrin, sucralose,
Questions Or Comments?
call 1-855-848-3284 (English & Spanish)
Package/Label Principal Display Panel
Children's Mylicon Tummy Relief For Kids (Image 01)
Great tasting Chewable Tablets!
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
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. |
* Please review the disclaimer below.
