ANNE GEDDES INFANT ANTI-GAS DROPS- simethicone liquid 
HR Pharma LLC

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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Anne Geddes  Infant Anti-Gas Drops

Active ingredient           Purpose:

(in each dose):

Simethicone 21mg ........ Anti-gas

Relieves symptoms referred to as gas

Keep this and all drugs out of the reach of children

In Case of accidental overdose, seek professional assistance or contact a poison control center immediately

Do not store above 75F (24C)

  • Administer .08 fl oz (2.5 ml) of Anti-gas Relief Drops while feeding
  • Do not use more than 6 doses in a 24 hour period
  • Use provided syringe to ensure accurate measurement
 Age (Yr)Weight (lb)        Dose
 Infants under 1Under 24  2.5 ml
 Children over 1Over 24 2.5 ml

Carbomer, Ethylparaben, Methylparaben, Peucedanum Graveolens (Dill) Extract, Propylparaben, Sodium Hydroxide, Sucrose, Water

Anne Geddes

Infant Anti-Gas Drops

3.4 fl oz (100 ml)

Carton

Wrap label

Syringe

ANNE GEDDES INFANT ANTI-GAS DROPS 
simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69976-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE21 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
Ethylparaben (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
dill (UNII: Y05PC4JZRH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Sucrose (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69976-003-021 in 1 CARTON09/22/201511/18/2016
1NDC:69976-003-01100 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/22/201511/18/2016
Labeler - HR Pharma LLC (079850639)
Registrant - Fleet Laboratories LTD (217269489)
Establishment
NameAddressID/FEIBusiness Operations
Fleet Laboratories LTD217269489manufacture(69976-003)

Revised: 6/2018
Document Id: 1830c47a-7def-4baa-8d39-a2ce382e7108
Set id: 05754a4c-90f3-4be1-828d-217d4034c97f
Version: 4
Effective Time: 20180619
 
HR Pharma LLC