Label: FOSTER AND THRIVE INFANTS GAS RELIEF- simethicone solution/ drops
- NDC Code(s): 70677-1078-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2024
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- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- WHEN USING THIS PRODUCT
- KEEP OUT OF REACH OF CHILDREN.
-
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 close the bottle to maintain child resistance
age (yr) weight (lb) dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL
- OTHER INFORMATION
- INACTIVE INGRADIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FOSTER AND THRIVE INFANTS GAS RELIEF
simethicone solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1078 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) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1078-1 1 in 1 CARTON 06/12/2023 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 Drug M 06/12/2023 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(70677-1078)