INFANTS- simethicone suspension/ drops 
RUGBY LABORATORIES

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Rugby® 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, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments?

1-800-645-2158

Principal Display Panel

Rugby®

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

NDC 0536-1303-75

Infants’

Simethicone Drops

Antigas

Dye-free
Non-staining formula
No Saccharin
No Artificial Color
No Artificial Flavor

1 FL OZ (30 mL) 100 DOSES

Distributed by:

RUGBY LABORATORIES

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Syringe Enclosed. This bottle contains 100 doses (0.3 mL/dose)

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

Rugbt Infants Simethicone Drops
INFANTS 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE, UNSPECIFIED20 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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1303-751 in 1 CARTON09/01/2020
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 DrugM00209/01/2020
Labeler - RUGBY LABORATORIES (079246066)

Revised: 10/2024
Document Id: 8127a100-e644-462a-9fb9-841024a87c9c
Set id: c6fa71bc-de48-47f4-80c4-7d92643d2664
Version: 5
Effective Time: 20241031
 
RUGBY LABORATORIES