LITTLE REMEDIES GAS RELIEF DROPS- simthicone liquid 
Denison 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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Little Remedies Gas Relief Drops

Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg

Purpose

Antigas

Uses

Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food.

Warnings

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • shake well before using
  • only use enclosed dropper / syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek
  • 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
  • dosage can also be mixed with 1 fl oz of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap

If possible, use weight to determine dose; otherwise use age.

mL = milliliter

Age (yrs)Weight (lbs)Dose
Newborns & Infants under 2Under 240.3 mL
Children 2 and over24 and over0.6 mL

Other information

  • do not freeze
  • store at room temperature 20°-25°C (68°-77°F)
  • see bottle or box for lot number and expiration date

Inactive ingredients

carmellose sodium (and) microcrystalline cellulose, citric acid, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

Questions?

1-800-754-8853

Mon. – Fri. 8:30 am to 5:30 pm EST

LittleRemedies.com

PRINCIPAL DISPLAY PANEL

Little Remedies
Gas Relief Drops
Simethicone / Antigas
0.5 FL OZ (15 mL)

Little Remedies Gas Relief Drops 0.5 FL OZ (15 mL) Carton

LITTLE REMEDIES  GAS RELIEF DROPS
simthicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1237
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 (UNII: K679OBS311)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1237-021 in 1 CARTON01/01/2017
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:0295-1237-051 in 1 CARTON01/01/2017
230 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 FINALpart33201/01/2017
Labeler - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208MANUFACTURE(0295-1237)

Revised: 1/2017
Document Id: 68524ce0-ca5f-48ef-860a-894ac02c4d29
Set id: b4318267-59f8-4b4b-ae80-c578f8b1fe80
Version: 1
Effective Time: 20170101
 
Denison Pharmaceuticals, Inc.