INFANTS GAS RELIEF- simethicone suspension/ drops 
Atlantic Biologicals Corps

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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MAJOR INFANT GAS RELIEF

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 (2 and over)
24 and over
0.6 mL

Other information

Inactive ingredients

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

Questions or comments?

(800)616-2471

HOW SUPPLIED

Product: 17856-5894

NDC: 17856-5894-1 10 mL in a CUP

NDC: 17856-5894-4 1.2 mL in a DOSE PACK / 60 in a CASE

INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS

image description

image description

INFANTS GAS RELIEF 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5894(NDC:0904-5894)
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)  
MALTITOL (UNII: D65DG142WK)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (off-white) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-5894-460 in 1 CASE06/30/2021
11.2 mL in 1 DOSE PACK; Type 0: Not a Combination Product
2NDC:17856-5894-110 mL in 1 CUP; Type 0: Not a Combination Product05/01/201506/30/2021
3NDC:17856-5894-3.3 mL in 1 SYRINGE; Type 0: Not a Combination Product06/30/2021
4NDC:17856-5894-7120 in 1 BOX, UNIT-DOSE06/30/2021
4.3 mL in 1 SYRINGE; Type 0: Not a Combination Product
5NDC:17856-5894-2120 in 1 BOX, UNIT-DOSE06/30/2021
50.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
6NDC:17856-5894-6120 in 1 BOX, UNIT-DOSE06/30/2021
60.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35612/07/2010
Labeler - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-5894) , REPACK(17856-5894)

Revised: 6/2021
Document Id: 02bce983-fd0b-4992-8889-9d988bdb7133
Set id: fa869550-a0a8-4359-8d23-d2d178090549
Version: 7
Effective Time: 20210630
 
Atlantic Biologicals Corps