INFANTS- simethicone suspension/ drops 
ATLANTIC BIOLOGICALS CORP.

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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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

Infants’

Simethicone Drops

Antigas

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

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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INFANTS 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1303(NDC:0536-1303)
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 FORM (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:17856-1303-1120 in 1 BOX, UNIT-DOSE06/30/2021
10.3 mL in 1 SYRINGE; Type 0: Not a Combination Product
2NDC:17856-1303-2120 in 1 BOX, UNIT-DOSE06/30/2021
20.3 mL in 1 SYRINGE; Type 0: Not a Combination Product
3NDC:17856-1303-3120 in 1 BOX, UNIT-DOSE06/30/2021
30.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
4NDC:17856-1303-4120 in 1 BOX, UNIT-DOSE06/30/2021
40.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
5NDC:17856-1303-560 in 1 BOX, UNIT-DOSE06/30/2021
51.2 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/01/2020
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-1303) , repack(17856-1303)

Revised: 6/2021
Document Id: cab6fc05-2985-46c3-9af4-f73542e6f644
Set id: 27fce442-e328-41d2-bab9-87ab21550c04
Version: 1
Effective Time: 20210630
 
ATLANTIC BIOLOGICALS CORP.