Label: INFANTS GAS RELIEF DYE FREE- simethicone antigas emulsion
- NDC Code(s): 30142-171-01
- Packager: THE KROGER CO.
- 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 August 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
-
Directions
- •
- shake well before using
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- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
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- all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
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- do not exceed 12 doses per day.
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- Fill enclosed dropper or syringe to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
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- dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
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- clean dropper well after each use-recap bottle with original cap
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- mL = milliliter
Age (yr)
Weight (lb)
Dose (mL)
infants under 2
under 24
0.3
children over 2
over 24
0.6
- Other information
- Inactive ingredients
-
Principal Display Panel
NDC# 30142-171-01
Dye Free Drops
INFANTS’ GAS RELIEF
*compare to the active ingredient of INFANTS’ MYLICON® DROPS
*see the side panel
Dye Free Drops
INFANTS’ GAS RELIEF
SIMETHICONE-ANTIGAS
- •
- Non-Staining formula
- •
- Gently Breaks Down Baby’s Gas Bubbles
- •
- No alcohol
- •
- No Artificial Colors or Flavor
1 Fl. OZ (30ml)
100 DOSES
IMPORTANT: Keep this carton for future reference on full labeling
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY INFIRST HEALTHCARE INC., THE DISTRIBUTOR OF INFANTS’ MYLICON® DROPS. INFIRST HEALTHCARE INC. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.
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INGREDIENTS AND APPEARANCE
INFANTS GAS RELIEF DYE FREE
simethicone antigas emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-171 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 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) 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:30142-171-01 1 in 1 CARTON 07/16/2019 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 07/16/2019 Labeler - THE KROGER CO. (006999528)
