Your browser does not support JavaScript! GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [RUGBY LABORATORIES, INC.]
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GAS RELIEF (simethicone) suspension/ drops
[Rugby Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antiflatulent

Use

relieves the bloating, pressure and fullness sypmtoms of gas

Warnings


Keep out of reach of children.

Directions

  •  shake well before using
  • dosages may be repeated as needed, after meals and at bedtime or as directed by a doctor but do not exceed 12 doses per day
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into mouth, toward inner cheek
  • may be mixed with 1 oz water, infant formula or other suitable liquid
  • for best results, clean dropper after each use and replace original cap

Age (years)Weight (lbs) Dose
infants (under 2)
under 24
0.3 mL
children (over 2)
over 24
0.6 mL

Other information

  • store at room temperature
  • do not freeze
  •  TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing

Inactive ingredients

carboxymethylcellulose sodium, citric acid, maltitol, microcrystalline cellulose, natural flavor, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

Call 1-800-645-2158, 9 am - 5 pm ET, Monday-Friday

package Label

compare to the active ingredient of MYLICON DROPS

RUGBY

NDC 0536-2220-75

GAS RELIEF DROPS
Simethicone Oral Suspension USP

Suitable for Infant Use
dye free formula

satisfaction guaranteed
Rugby
or you money back

1 FL OZ (30 mL)
Infant gas relief label



GAS RELIEF  
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-2220
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
ANHYDROUS CITRIC ACID 
MALTITOL 
CELLULOSE, MICROCRYSTALLINE 
WATER 
SODIUM BENZOATE 
ANHYDROUS TRISODIUM CITRATE 
XANTHAN GUM 
Product Characteristics
Colorwhite (off-white) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-2220-751 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33212/01/2010
Labeler - Rugby Laboratories, Inc. (109178264)
Registrant - GCP Laboratories (965480861)

Revised: 06/2012
 
Rugby Laboratories, Inc.

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