CARDINAL HEALTH INFANTS GAS RELIEF- simethicone suspension/ drops 
CARDINAL HEALTH

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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Cardinal Infants’ 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, 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 bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, 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

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

NDC 70000-0051-1

Infants’

Gas Relief Drops

Simethicone/Antigas

Dye-free

Non-staining formula

No Alcohol/No Saccharin
No Artificial Color
No Artificial Flavor

1 FL OZ (30 mL) 100 DOSES

Distributed by:

IMPORTANT: Keep this carton for future reference on full labeling.

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

Cardinal Health Infants Gas Relief
CARDINAL HEALTH INFANTS GAS RELIEF 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0051
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
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0051-11 in 1 CARTON09/02/2020
130 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 finalpart33209/02/2020
Labeler - CARDINAL HEALTH (063997360)

Revised: 10/2023
Document Id: 2514dc38-f5be-4534-a2e4-cec992c97edb
Set id: e0dec270-dabb-4289-b5e0-bf37f9ddcbcd
Version: 5
Effective Time: 20231004
 
CARDINAL HEALTH