MYLICON- simethicone suspension 
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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hst infants 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 240.3 mL

children (2 and over)

24 and over0.6 mL

Other information

Inactive ingredients

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

Questions or comments?

1-800-540-3765

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Package Label

image 1

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MYLICON 
simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0799(NDC:57896-798)
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
MALTITOL (UNII: D65DG142WK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0799-1120 in 1 BOX, UNIT-DOSE04/06/2023
10.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:17856-0799-2120 in 1 BOX, UNIT-DOSE04/06/2023
20.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:17856-0799-3120 in 1 BOX, UNIT-DOSE04/06/2023
30.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:17856-0799-4120 in 1 BOX, UNIT-DOSE04/06/2023
40.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:17856-0799-560 in 1 BOX, UNIT-DOSE04/06/2023
51.2 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33205/01/2014
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-0799)

Revised: 5/2023
Document Id: eb3941c1-96e7-4bf4-9baf-d18398829439
Set id: e47eca0a-4678-4c72-97f0-144e6aa06520
Version: 5
Effective Time: 20230516
 
ATLANTIC BIOLOGICALS CORP.