INFANTS GAS DROPS- simethicone suspension/ drops 
Rij Pharmaceutical Corporation

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.

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Drug Facts

Active ingredients (in each 0.3mL)

Simethicone 20 mg

Purpose

Antigas

Uses

Relieves the discomfort of gas frequently caused by air swallowing, or certain formulas or foods.

Warnings

Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.
fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek
dosage can also be mixed with 1 oz.of cool water, infant formula or other suitable liquids
for best results, clean dropper after each use and replace original cap.
Age (yrs)Weight (lbs)Dose (ml)
Infants under 2Under 240.3 mL
Children over 2Over 240.6 mL

Other Information

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
Store at room temperature 15° - 30°C (59 - 86°F)
protect from freezing
each 0.3 mL contains: sodium 1 mg

Inactive ingredients

carbopol - 934-P, citric acid, FD&C red #3, flavor, hypromellose, sodium benzoate, sodium citrate, sodium hypoclorite, sodium saccharin, water

Principal Display Panel

Gas Drops Label

INFANTS GAS DROPS 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-523
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM (UNII: 9NEZ333N27)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-523-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33203/16/1996
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-523)

Revised: 4/2018
Document Id: 39eeac36-8c1d-4a1b-9bf8-5e59c9050f66
Set id: 469749d4-c83d-48d0-a14b-1e26ff880e33
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation