FDA Label for Childrens Mylicon All In One Tummy Relief For Kids
View Indications, Usage & Precautions
Childrens Mylicon All In One Tummy Relief For Kids Product Label
The following document was submitted to the FDA by the labeler of this product Infirst Healthcare Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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.
* Please review the disclaimer below.