Gas Relief by TOP CARE (Topco Associates LLC) / P & L Development, LLC DRUG FACTS

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled 
TOP CARE (Topco Associates 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.

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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

• adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
• do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
• protect from heat and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, titanium dioxide

Questions or comments?

Call toll free: 1-888-423-0139

Principal Display Panel

EXTRA STRENGTH

Gas Relief

Simethicone, 125 mg

• Relieves bloating, pressure, fullness and gas

COMPARE TO EXTRA STRENGTH GAS-X® active ingredient*

SOFTGELS

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Gas-X®.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

Product Label

Top Care Gas Relief Softgel

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-550
Route of Administration	ORAL

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: 36800-550-30	2 in 1 CARTON	05/31/2013	12/31/2019
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 36800-550-50	5 in 1 CARTON	05/31/2013	12/31/2019
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/31/2013	12/31/2019

Labeler - TOP CARE (Topco Associates LLC) (006935977)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: ba857381-0701-48c3-946b-d85630b1e3fe

34390-5

Set id: d8b7804e-8093-491a-80ad-057fe9a702ae

Version: 2

Effective Time: 20181227

 

TOP CARE (Topco Associates LLC)