Label: INFANTS GAS RELIEF DROPS- simethicone emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 15127-042-17 - Packager: Select Brand
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 5, 2014
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
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Directions
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime
- fill enclosed dropper to recommend dosage level
- dispense liquid slowly into baby's mouth, toward the inner cheek
- may mix with 1 oz. of cool water, infant formula or other suitable liquids
- clean dropper after each use and close the bottle to maintain child resistance
age (yr)
weight (lb)
dose
infants under2
under 24
0.3 mL
children over 2
over 24
0.6 mL
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
INFANTS GAS RELIEF DROPS
simethicone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-042 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 SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) BENZOIC ACID (UNII: 8SKN0B0MIM) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15127-042-17 1 in 1 CARTON 1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 02/02/2013 Labeler - Select Brand (043562370)