OTC Medication Information: Gas Relief Extra Strength

GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled
P & L Development, 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.

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 except under the advice and supervision of a physican

Other information

  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • protect from light, heat, and moisture

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

extra strength

gas relief

simethicone 125 mg

anti-gas

fast relief of

  • Pressure
  • bloating
  • discomfort

softgels

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street, Westbury, NY 11590

Product Label

Simethicone 125 mg
(click image for full-size original)

WELLNESS BASICS Extra Strength Gas Relief

GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-097
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) 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
SORBITAN
SORBITOL
TITANIUM DIOXIDE
MANNITOL
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 9mm
Flavor Imprint Code PO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59726-097-30 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (59726-097-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 08/30/2019
Labeler — P & L Development, LLC (800014821)

Revised: 09/2019 P & L Development, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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