Label: PEDIACARE SIMETHICONE ANTIGAS- simethicone emulsion
- NDC Code(s): 59556-853-59
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 9, 2017
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- Drug Facts
- Active ingredient
- 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
24 and over
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
PEDIACARE SIMETHICONE ANTIGAS
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)