Gas Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Gas Relief

BJWC (Berkley & Jensen / BJ's)

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

  • for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions


  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours unless directed by a doctor

Other information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protect from light, heat, and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, medium-chain triglycerides*, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

*may contain this ingredient

Questions or comments?

Call toll free 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

GAS RELIEF

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE, 125 mg

ANTIGAS

RELIEVES:

• BLOATING   • FULLNESS

• PRESSURE   •GAS

Compare to the active ingredient in Gas-X®†

SOFTGELS  125 mg EACH

†This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by BJWC

25 Research Drive

Westborough, MA 01581

Product Label

Product Label
Berkley & Jensen Extra Strength Gas Relief Softgel

Gas Relief

SIMETHICONE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68391-242
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
MEDIUM-CHAIN TRIGLYCERIDES
PEPPERMINT OIL
water
SORBITAN
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 9 mm PO;S1;SCU OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BLISTER PACK
2 NDC:68391-242-12 8 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2013-10-15


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Be sure to consult your doctor before taking any medication!
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