INFANTS- simethicone suspension/ drops

Infants by

Drug Labeling and Warnings

Infants by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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-freeNon-staining formulaNo SaccharinNo Artificial ColorNo Artificial Flavor

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

INGREDIENTS AND APPEARANCE

INFANTS 
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-1303(NDC:0536-1303)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-1303-1	120 in 1 BOX, UNIT-DOSE	06/30/2021
1		0.3 mL in 1 SYRINGE; Type 0: Not a Combination Product
2	NDC: 17856-1303-2	120 in 1 BOX, UNIT-DOSE	06/30/2021
2		0.3 mL in 1 SYRINGE; Type 0: Not a Combination Product
3	NDC: 17856-1303-3	120 in 1 BOX, UNIT-DOSE	06/30/2021
3		0.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
4	NDC: 17856-1303-4	120 in 1 BOX, UNIT-DOSE	06/30/2021
4		0.6 mL in 1 SYRINGE; Type 0: Not a Combination Product
5	NDC: 17856-1303-5	60 in 1 BOX, UNIT-DOSE	06/30/2021
5		1.2 mL in 1 SYRINGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	09/01/2020

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	relabel(17856-1303) , repack(17856-1303)