OTC Medication Information: Gas Relief

GAS RELIEF — dimethicone tablet, chewable
Strategic Sourcing Services 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 tablet)

simethicone 125 mg

Purpose

Anti-gas

Uses

relieves:

  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other information

  • do not use if any individual blister unit is broken or open
  • store at room temperature
  • avoid high humidity and excessive heat, above 40o C (104o F)

Inactive ingredients

D&C red 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Principal Display Panel

sunmark

COMPARE TO GAS-X EXTRA STRENGTH ACTIVE INGREDIENT*

NDC 49348-863-48

gas relief

Extra Strength

Relieves these gas symptoms:

Discomfort, pressure & bloating

ANTIGAS SIMETHICONE 125 mg

CHERRY CREME FLAVOR

18 CHEWABLE TABLETS

box
(click image for full-size original)
GAS RELIEF
simethicone tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-863
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 RED NO. 30
DEXTROSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
SORBITOL
SUCROSE
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor CHERRY Imprint Code G134
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49348-863-48 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 9 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (49348-863-48)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 10/01/2012
Labeler — Strategic Sourcing Services LLC (116956644)
Registrant — Guardian Drug Company (119210276)

Revised: 09/2019 Strategic Sourcing Services 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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