Mylicon Infants Gas Relief Dye Free

Mylicon Infants Gas Relief Dye Free
SPL v6
SPL
SPL Set ID 3324139a-ed22-43af-859d-e7af19a24ee9
Route
ORAL
Published
Effective Date 2019-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Form Anhydrous Citric Acid Microcrystalline Cellulose Polysorbate 60 Potassium Sorbate Water Sodium Benzoate Sorbitan Monostearate Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-31

Description

Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Uses

relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Directions
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into the bottle
  • pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
  • all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
  • do not exceed 12 doses per day.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • replace cap tightly to maintain child resistance
  • mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Active Ingredient

Simethicone 20 mg

Other Information
  • tamper evident: do not use if printed seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not freeze
  • see bottom panel for lot number and expiration date
Inactive Ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Principal Display Panel

Mylicon® Infants' Drops

Simethicone-Antigas

Gas Relief

Gently breaks down baby’s gas bubbles

Dye Free Drops

Non-staining

Safe enough to use at every feeding and up to 12 times per day*

#1 Brand

Recommended by Pediatricians

Visit us at mylicon.com

No Alcohol

No Artificial Flavors

No Saccharin

Gluten Free

Safe enough to use at every feeding and up to 12 times per day*

Safe enough for even the newest of newborns

*use as directed

Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Important: Keep this carton for future reference on full labeling

Manufactured for

infirst Healthcare Inc.

Westport, CT 06880

©2015 infirst Healthcare Inc.

MYLICON ARTWORK 100 DOESE

Questions Or Comments ?

Call 1-855-848-3284 toll free (English and Spanish)

Mylicon Artwork 50 Doese
Keep Out of Reach of Children.

Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.


Structured Label Content

Uses

relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Purpose

Antigas

Directions
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • remove cap and insert syringe into the bottle
  • pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
  • all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
  • do not exceed 12 doses per day.
  • dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
  • replace cap tightly to maintain child resistance
  • mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Active Ingredient (Active ingredient)

Simethicone 20 mg

Other Information (Other information)
  • tamper evident: do not use if printed seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • do not freeze
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Principal Display Panel

Mylicon® Infants' Drops

Simethicone-Antigas

Gas Relief

Gently breaks down baby’s gas bubbles

Dye Free Drops

Non-staining

Safe enough to use at every feeding and up to 12 times per day*

#1 Brand

Recommended by Pediatricians

Visit us at mylicon.com

No Alcohol

No Artificial Flavors

No Saccharin

Gluten Free

Safe enough to use at every feeding and up to 12 times per day*

Safe enough for even the newest of newborns

*use as directed

Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Important: Keep this carton for future reference on full labeling

Manufactured for

infirst Healthcare Inc.

Westport, CT 06880

©2015 infirst Healthcare Inc.

MYLICON ARTWORK 100 DOESE

Questions Or Comments ? (Questions or comments ?)

Call 1-855-848-3284 toll free (English and Spanish)

Mylicon Artwork 50 Doese (MYLICON ARTWORK 50 DOESE)
Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.


Advanced Ingredient Data


Raw Label Data

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