Label: SUNMARK INFANTS GAS RELIEF DROPS- simethicone emulsion
- 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 10, 2012
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- Active ingredient (in each 0.3 mL)
- shake well before using
- all dosages may be repeated as needed, after meals and at bedtime
- fill enclosed dropper to recommended 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 replace original cap.
age (yr) weight (lb)
infants under 2
under 24 0.3 mL children over 2
over 24 0.6 mL
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
SUNMARK INFANTS GAS RELIEF DROPS
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-577 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 BENZOIC ACID (UNII: 8SKN0B0MIM) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) 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:49348-577-34 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 10/31/2003 Labeler - McKesson (177667227)