Label: INFANTS GAS RELIEF- simethicone solution/ drops
- NDC Code(s): 41163-096-09
- Packager: Supervalu 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.
Drug Label Information
Updated May 12, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (in each 0.3 mL)
- PURPOSE
- USE(S)
- WARNINGS
- WHEN USING THIS PRODUCT
- KEEP OUT OF THE 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 INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
INFANTS GAS RELIEF
simethicone solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-096 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 (off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-096-09 1 in 1 CARTON 08/26/2021 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 08/26/2021 Labeler - Supervalu Inc. (006961411) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(41163-096)
