children’s mylicon tummy relief for kids

children’s mylicon tummy relief for kids
SPL v4
SPL
SPL Set ID 432d5b4c-a69b-45f9-b7f0-216726a3eead
Route
oral
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carbonate ion (400 mg) dimethicone (40 mg)
Inactive Ingredients
adipic acid crospovidone (15 mpa.s at 5%) d&c red no. 27 dextrose, unspecified form magnesium stearate maltodextrin sucralose

Identifiers & Packaging

Pill Appearance
Imprint: myc Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-02-09 Until 2023-06-01

Purpose

Antacid Antigas

Description

Calcium carbonate 400 mg Simethicone 40 mg


Medication Information

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
  • 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
  • e ach 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,

Description

Calcium carbonate 400 mg Simethicone 40 mg

Purposes

Antacid

Antigas

Active Ingredients

Calcium carbonate 400 mg

Simethicone 40 mg

Questions Or Comments?

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

Children Mylicon Pouch Pack
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

Great tasting Chewable Tablets!

  • New!

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

  • Multi- Symptom Relief for Upset Tummies
  • Multi-Symptom Tummy Relief for Kids

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.

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
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 (Other information)
  • e ach chewable tablet contains:calcium 160 mg
  • store between 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

adipic acid, crospovidone, D&C red 27, dextrose, flavors, magnesium stearate, maltodextrin, sucralose,

Purposes

Antacid

Antigas

Active Ingredients (Active ingredients)

Calcium carbonate 400 mg

Simethicone 40 mg

Questions Or Comments? (Questions or comments?)

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

Children Mylicon Pouch Pack
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)

Great tasting Chewable Tablets!

  • New!

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

  • Multi- Symptom Relief for Upset Tummies
  • Multi-Symptom Tummy Relief for Kids

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.

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.


Advanced Ingredient Data


Raw Label Data

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