Gas Relief: Package Insert and Label Information

GAS RELIEF- dimethicone tablet, chewable
Meijer Distribution, Inc.

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 chewable tablet)

Simethicone 125 mg

Purpose

Antigas

Uses

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

Warnings

Keep out of reach of children.

Directions

  • do not take more than directed

  • chew or crush tablets completely before swallowing; do not swallow tablets whole

  • adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime

  • do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • each tablet contains: calcium 85 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions or comments?

1-800-426-9391

Principal display panel

NDC 79481-0608-4

Meijer®

Compare to
Gas-X® Extra Strength
active ingredient*

EXTRA STRENGTH

gas relief
Simethicone | 125 mg
Chewable Tablets
Anti-Gas

Relieves:
Pressure, Bloating, Discomfort

18 Tablets

Actual Size
Cherry Flavor

Chew or crush
tablets completely
before swallowing.

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

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.50844 ORG122060844

Meijer 44-608
(click image for full-size original)

Meijer 44-608

GAS RELIEF simethicone tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0608
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
CROSPOVIDONE
D&C RED NO. 27 ALUMINUM LAKE
D&C RED NO. 30
DEXTROSE MONOHYDRATE
FD&C RED NO. 40
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
SUCRALOSE
TRIBASIC CALCIUM PHOSPHATE
DIMETHICONE 410
Product Characteristics
Color pink Score no score
Shape ROUND Size 14mm
Flavor CHERRY Imprint Code 44;608
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79481-0608-4 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 (79481-0608-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 12/28/2020
Labeler — Meijer Distribution, Inc. (006959555)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (79481-0608)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (79481-0608)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (79481-0608)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (79481-0608)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (79481-0608)

Revised: 01/2022 Meijer Distribution, Inc.

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