GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled 
Navarro Discount Pharmacies,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.

----------

Drug Facts

Active Ingredients (in each softgel)

Simethicone 125mg

Purpose

Antiflatulent

Uses

For Relief of:

Warnings

Stop use and ask a doctor if

condition persists

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingreients

FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide

Package/Label Principal Display Panel

image description

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59970-078
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color green Score no score
Shape OVAL Size 9mm
Flavor Imprint Code GR
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59970-078-30 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 01/21/2013
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 10/2012
Document Id: f9c0247e-48e0-40c8-8c96-26b081ade220
Set id: f424e579-4a1a-4973-8386-6eec6b57fc0b
Version: 1
Effective Time: 20121026
 
Navarro Discount Pharmacies,LLC