Equate Infants' Gas Relief Drops Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

EQUATE INFANTS GAS RELIEF- simethicone emulsion 
Raritan Pharmaceuticals Inc

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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Equate Infants' Gas Relief Drops Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the discomfort of infant 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. cool water, infant formula or other suitable liquids
  • clean dropper after each use - replace bottle with 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

  • store at room temperature (59°-86°F)
  • do not freeze
  • see bottom panel for lot and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, PEG-40 monostearate, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol.

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to active ingredient of Mylicon® Drops

*See Side Panel

Infants' Gas Relief

Simethicone 20 mg Drops

Safe enough to use at every feeding**

Dye Free

Non-Staining

No alcohol or saccharin

No artificial flavors

No artificial colors

**Use as directed

1 Fl. OZ (30ml)

100 Doses

Equate Infants' Gas Relief Drops

Equate Infants' Gas Relief Drops

EQUATE INFANTS GAS RELIEF 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68163-709
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68163-709-021 in 1 CARTON03/08/201009/07/2019
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/08/201009/07/2019
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2019
Document Id: d36c343c-ba2e-4d57-a43a-3d37921856b6
Set id: 893fa061-ba83-485e-a9dc-822313b6065d
Version: 2
Effective Time: 20190909