GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled 
Care One (American Sales Company)

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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DRUG FACTS

Drug Facts

Active Ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antiflatulent (Antigas)

Use

relieves bloating, pressure, or fullness commonly referred to as gas.

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

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from heat and moisture
  • *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Extra Strength Gas- X®

Inactive Ingredients

D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

Questions or comments?

call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Extra Strength Gas-X®*

Extra Strength

GAS RELIEF

Simethicone 125 mg

relieves:

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: American Sales Company

4201 walden ave, Lancaster, NY 14086

www.care1.com

Product Label

CareOne

Simethicone 125 mg

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-550
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 9mm
Flavor Imprint Code PO
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-550-30 2 in 1 CARTON
1 15 in 1 BLISTER PACK
2 NDC:41520-550-36 2 in 1 CARTON
2 18 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part332 10/27/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 50f7fd7d-cdcd-4e5d-8cbd-8c307d74f40d
Set id: eeae6bcb-9d38-4d0b-ad00-1f019225a2c6
Version: 1
Effective Time: 20121227
 
Care One (American Sales Company)