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Gas relief

Care One (American Sales Company)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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
  • *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:

  • pressure
  • bloating 
  • fullness 
  • gas

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

Gas relief
Simethicone 125 mg

Gas relief

SIMETHICONE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-550
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 125 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
PEPPERMINT OIL
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 9 mm PO OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BLISTER PACK
2 18 in 1 BLISTER PACK
3 NDC:41520-550-36 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 2010-10-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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