Children’s Mylicon All-in-one Tummy Relief For Kids

Children’s Mylicon All-in-one Tummy Relief For Kids
SPL v2
SPL
SPL Set ID 0952eba8-6de2-4a77-956d-339fab437472
Route
ORAL
Published
Effective Date 2022-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (400 mg) Dimethicone (40 mg)
Inactive Ingredients
Benzyl Alcohol Carboxymethylcellulose Sodium, Unspecified D&c Red No. 28 Glycerin Microcrystalline Cellulose Water Sodium Carbonate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-24

Description

Calcium carbonate 400 mg Simethicone 40 mg

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid

Antigas

Description

Calcium carbonate 400 mg Simethicone 40 mg

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
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
Active Ingredients

Calcium carbonate 400 mg

Simethicone 40 mg

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)

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

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.

Ask A Doctor Or Pharmacist Before Use If

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


Structured Label Content

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
Purpose

Antacid

Antigas

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

Calcium carbonate 400 mg

Simethicone 40 mg

Inactive Ingredients (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? (Questions or comments?)

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

Keep Out of Reach of Children. (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

Package/label Principal Display Panel (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.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

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


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