CVS HEALTH INFANT GAS RELIEF- simethicone suspension/ drops 
CVS PHARMACY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Health Gas Relief Simethicone Drops

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, if you passed the prescribed level, simply push syringe back until you have reached the desired 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 bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, natural berry flavors, microcrystalline cellulose, 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 Little Remedies® Gas Relief*

50 Infant Doses

NDC# 69842-979.15

Gas Relief

SIMETHICONE 20 mg

ANTIGAS

DYE FREE

Actual Bottle size on Side Panel

0.5 FL OZ (15 mL)

*This product is not manufactured or distributed by Medtech Products Inc., the distributor of Little Remedies® Gas Relief Drops.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

@ 2020 CVS/pharmacy CVS.com®

1-800-SHOP CVS

V-31765

CVS Quality

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IMPORTANT: Keep this Carton for future reference on full labeling

Package Label 50 Infant Doses

CVS Health Infant Gas Relief 50 doses
CVS HEALTH INFANT  GAS RELIEF
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-979
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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
ColorPINKScore    
ShapeSize
FlavorBERRY (natural) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-979-151 in 1 CARTON12/23/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33212/23/2019
Labeler - CVS PHARMACY (062312574)

Revised: 9/2023
Document Id: 4880fbdf-cf5a-4a73-8817-0649bf856cde
Set id: 088993c1-31f0-4270-a3df-a585e7c8d511
Version: 5
Effective Time: 20230913
 
CVS PHARMACY