INFANTS GAS RELIEF- simethicone suspension/ drops

Infants Gas Relief by

Drug Labeling and Warnings

Infants Gas Relief by is a Otc medication manufactured, distributed, or labeled by Atlantic Biologicals Corps. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

•  shake well before using
• 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
• fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward inner cheek
• dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
• clean dropper well after each use and replace original cap

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

• TAMPER-EVIDENT: Do not use if foil 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, 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

NDC: 17856-5894-03

INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS

NDC: 17856-5894-07 

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF 
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-5894(NDC:0904-5894)
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)
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
Color	white (off-white)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-5894-4	60 in 1 CASE	03/01/2018
1		1.2 mL in 1 DOSE PACK; Type 0: Not a Combination Product
2	NDC: 17856-5894-1	10 mL in 1 CUP; Type 0: Not a Combination Product	05/01/2015
3	NDC: 17856-5894-3	.3 mL in 1 SYRINGE; Type 0: Not a Combination Product	05/18/2018
4	NDC: 17856-5894-7	120 in 1 BOX, UNIT-DOSE	10/05/2018
4		.3 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 NOT FINAL	part356	12/07/2010

Labeler - Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
Atlantic Biologicals Corps		047437707	RELABEL(17856-5894) , REPACK(17856-5894)