GAS RELIEF- 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 infant drops

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Use

relieves the symptoms referred to as gas

Warnings


Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

Age (years)Weight (lbs) Dose
infants (under 2)
under 24
0.3 mL
children (over 2)
over 24
0.6 mL

Other information

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions or comments?

1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

package Label

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GAS RELIEF 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-2220(NDC:0536-2220)
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 (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MALTITOL (UNII: D65DG142WK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (off-white) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-2220-1120 in 1 BOX, UNIT-DOSE08/17/2020
10.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
2NDC:17856-2220-2120 in 1 BOX, UNIT-DOSE08/17/2020
20.3 mL in 1 SYRINGE; Type 0: Not a Combination Product
3NDC:17856-2220-3120 in 1 BOX, UNIT-DOSE08/17/2020
30.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
4NDC:17856-2220-4120 in 1 BOX, UNIT-DOSE08/17/2020
40.3 mL in 1 SYRINGE; Type 0: Not a Combination Product
5NDC:17856-2220-560 in 1 BOX, UNIT-DOSE08/17/2020
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 finalpart33212/01/2010
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-2220, 17856-2220)

Revised: 8/2020
Document Id: 9dd70b84-6d16-4a1d-b56f-5111091ab20e
Set id: b7f8335c-f853-4098-8960-e6c892f8ab0d
Version: 1
Effective Time: 20200817
 
ATLANTIC BIOLOGICALS CORP.