PEDIACARE SIMETHICONE ANTIGAS- simethicone emulsion

Pediacare SIMETHICONE ANTIGAS by

Drug Labeling and Warnings

Pediacare SIMETHICONE ANTIGAS by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

(in each 0.3 mL)

Simethicone 20 mg

(provided as simethicone emulsion 66.7 mg)

Purpose

Antigas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake well before using
• find right dose on chart below. If possible, use weight to determine dose; otherwise, use age.
• measure only with the enclosed syringe
• remove cap and insert syringe into the bottle. Fill syringe to recommended dosage level.
• dispense liquid slowly into child's mouth, toward inner cheek
• may be mixed with 1 oz. of cool water, infant formula or other suitable liquids
• 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
• clean syringe and replace cap tightly on bottle
• mL = millilitre

Age(yrs)	weight(lbs)	dose
infants; under 2	under 24	0.3mL
children 2; and over	24 and over	0.6mL

Other information

• do not freeze
• store at 20°-25°C (68°-77°F)

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate , sucralose, xanthan gum

Questions

1-888-474-3099 

Monday – Friday 8 am to 5 pm

Eastern standard time.

PediaCare.com

Principal Display Panel

INFANTS 0-36 months

PediaCare® 

Gas Relief DROPS

SIMETHICONE-ANTIGAS

DYE-FREE Berry Flavor

1 FL OZ (30 mL)

Carton

Label

INGREDIENTS AND APPEARANCE

PEDIACARE SIMETHICONE ANTIGAS 
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-853
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	0.011 g  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.211 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-853-59	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	08/01/2011

Labeler - Strides Pharma Inc (078868278)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	MANUFACTURE(59556-853)