GAS RELIEF: Package Insert and Label Information

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 80 mg

Purpose

Anti-Gas

Uses

relieves 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

  • chew or crush tablet completely before swallowing
  • adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.

Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.

  • children under 12 years: ask a doctor

Other information

  • each tablet contains: calcium 65 mg
  • store at room temperature, 15°C — 30°C (59˚F — 86˚F)
  • protect from moisture

Inactive ingredients

cellulose, corn starch, crospovidone, dextrates hydrated, flavor, magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

1-800-540-3765

package label

1
(click image for full-size original)

GAS RELIEF
simethicone tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-147
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 80 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DEXTRATES
MAGNESIUM STEARATE
STARCH, CORN
CROSPOVIDONE
SUCRALOSE
CALCIUM PHOSPHATE
SILICON DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor PEPPERMINT Imprint Code 44;137
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49348-147-07 1 BOTTLE in 1 CARTON contains a BOTTLE
1 36 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (49348-147-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 04/01/2016
Labeler — STRATEGIC SOURCING SERVICES LLC (116956644)
Registrant — Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 11/2022 STRATEGIC SOURCING SERVICES LLC

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