- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 0.3mL)
- Purpose
- Uses
- Warnings
-
Directions
- 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 and replace original cap.
age (yr) weight (lb) dose infants under 2 under 24 0.3mL children 2 and over over 24 0.6 mL - Other information
- Inactive ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
GAS RELIEF DROPS
dimethicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70570-0197 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 Anise Oil (UNII: 6Y89129C8H) Carboxypolymethylene (UNII: 0A5MM307FC) Glycerin (UNII: PDC6A3C0OX) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Water (UNII: 059QF0KO0R) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Sucralose (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70570-0197-1 1 in 1 CARTON 02/01/2015 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 02/01/2015 Labeler - Arymar Inc. (021650273)