Cvs Health ™

Cvs Health ™
SPL v12
SPL
SPL Set ID 352b1d0e-c6dc-491e-b3e2-c3d9dac3213b
Route
ORAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-10

Description

Simethicone Emulsion 66.65 mg/Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone Emulsion 66.65 mg/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, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards 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

Other Information
  • tamper evident: do not use if printed seal under cap is broken or missing
  • Store at room temperature
  • do not freeze
  • see carton for full labelling
Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, potassium sorbate, purified water, sodium benzoate, , sorbitol, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

CVSHealth®

Compare to the active ingredient in Infants’ Mylicon ®Drops *

NDC 69842-977-01

Infants’

Gas Relief

SIMETHICONE /ANTI-GAS

SUPPORTS BABY’S BODY IN RELIEVING GAS†

Anti-gas

  • Safe enough to use at every feeding‡
  • Non-staining

DYE FREE

Actual Product size on Side Panel

1 FL OZ (30mL)

*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon ®Drops..

†This medicine in CVS Health® Gas Relief Drops breaks down gas bubbles, helping a baby’s natural process of expelling gas.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

@ 2020 CVS/pharmacy CVS.com ®

1-800-SHOP CVS

V-12431

CVS Quality

Money Back Guarantee

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

Package Label Infants Gas Relief Dye-Free Formula 100 Doses

Active Ingredient (in Each 0.3 Ml)

Simethicone Emulsion 66.65 mg/Simethicone 20 mg

Package Label for Infant’s Gas Relief 50 Doses

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, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards 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

Other Information (Other information)
  • tamper evident: do not use if printed seal under cap is broken or missing
  • Store at room temperature
  • do not freeze
  • see carton for full labelling
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, potassium sorbate, purified water, sodium benzoate, , sorbitol, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

CVSHealth®

Compare to the active ingredient in Infants’ Mylicon ®Drops *

NDC 69842-977-01

Infants’

Gas Relief

SIMETHICONE /ANTI-GAS

SUPPORTS BABY’S BODY IN RELIEVING GAS†

Anti-gas

  • Safe enough to use at every feeding‡
  • Non-staining

DYE FREE

Actual Product size on Side Panel

1 FL OZ (30mL)

*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon ®Drops..

†This medicine in CVS Health® Gas Relief Drops breaks down gas bubbles, helping a baby’s natural process of expelling gas.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

@ 2020 CVS/pharmacy CVS.com ®

1-800-SHOP CVS

V-12431

CVS Quality

Money Back Guarantee

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

Package Label Infants Gas Relief Dye-Free Formula 100 Doses

Active Ingredient (in Each 0.3 Ml) (Active ingredient (in each 0.3 mL))

Simethicone Emulsion 66.65 mg/Simethicone 20 mg

Package Label for Infant’s Gas Relief 50 Doses

Advanced Ingredient Data


Raw Label Data

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