Label: INFANTS GAS RELIEF NON-STAINING FORMULA- dimethicone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-5773-01 - Packager: Walgreens
- 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 December 3, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
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Directions
- shake well before using
- all doses may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day
- only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
- remove cap and insert syringe into hole at top of bottle and turn upside down. Pull back plunger of syringe until syringe filled slightly over prescribed level. Turn to original position, simply push plunger back until you have reached the prescribe level. Pull syringe out of the bottle and dispense liquid slowly into baby's mouth, toward the inner cheek.
- dosage can be mixed with 1 oz. of cool water, infant formula or other suitable liquids
- for best results, clean syringe after each use and replace original cap
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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 2-Bottle Carton
TWIN PACK X 1 FL OZ = 2 FL OZ
Well at
WalgreensWALGREENS PHARMACIST RECOMMENDED‡
Infants'
Gas Relief
Simethicone 20 mg/Dose
Anti-Gas• Nonstaining formula • No alcohol
• No saccharin • No artificial flavor
• New dosing syringe design
200 DOSES
Compare to Infants' Mylicon®
Drops active ingredient‡‡2-1 FL OZ (30 mL) BOTTLES TOTAL 2 FL OZ (60 mL)
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INGREDIENTS AND APPEARANCE
INFANTS GAS RELIEF NON-STAINING FORMULA
dimethicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5773 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 SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYPROMELLOSES (UNII: 3NXW29V3WO) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) SUCRALOSE (UNII: 96K6UQ3ZD4) VANILLIN (UNII: CHI530446X) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor VANILLA, STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5773-01 2 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 06/15/2013 Labeler - Walgreens (008965063) Registrant - davAgen Pharmaceutical, LLC (967545935) Establishment Name Address ID/FEI Business Operations davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(0363-5773) , PACK(0363-5773) , LABEL(0363-5773) , ANALYSIS(0363-5773)