CVS HEALTH ANTI GAS- simethicone suspension/ drops

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

Simethicone 20 mg
Purpose

Antigas
Uses

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

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.
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 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, D&C Red 22, D&C Red 28, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments?

1-866-467-2748
Principal Display Panel
CVS Health™

Compare to the active ingredient in infants’ Mylicon® Gas Relief*

Infants’

Gas Relief

SIMETHICONE Anti-gas

SIMETHICONE

Anti-gas
- No alcohol
- No saccharin
- No artificial flavor
Actual Product size on Side Panel

100 DOSES 1 FL OZ (30 mL)

*This product is not manufactured or distributed by JOHNSON & JOHNSON-MERCK, Consumer Pharmaceuticals Co., the distributor of Infants’ Mylicon® Gas Relief.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

@ 2015 CVS/pharmacy CVS.com®

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IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

Package Label Infants Gas Relief Dye-Free Formula 100 Doses

Package Label for Infant’s Gas Relief 50 Doses

CVS HEALTH ANTI GAS
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-977
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 69842-977-01	1 in 1 CARTON	04/10/2019
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 69842-977-15	1 in 1 CARTON	04/10/2019
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	04/10/2019

Labeler - CVS PHARMACY (062312574)

CVS HEALTH ANTI GAS- simethicone suspension/ drops

CVS Health Anti gas by

Drug Labeling and Warnings

Drug Details [pdf]

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.

Questions or comments?

Package Label for Infant’s Gas Relief 50 Doses

Age (yr)	Weight (lb)	Dose (mL)
infants under 2	under 24	0.3
children over 2	over 24	0.6

CVS HEALTH ANTI GAS- simethicone suspension/ drops

CVS Health Anti gas by

Drug Labeling and Warnings

Drug Details [pdf]

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.

Questions or comments?

Package Label for Infant’s Gas Relief 50 Doses

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.