Leader 44-137

Leader 44-137
SPL v1
SPL
SPL Set ID 69840f03-0fbb-49b4-a85f-e85f3f22cf20
Route
ORAL
Published
Effective Date 2012-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (80 mg)
Inactive Ingredients
Dextrose Silicon Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: 44;137 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 1995-05-17
Description

 Simethicone 80 mg

Purpose

 Antigas

Medication Information

Purpose

 Antigas

Description

 Simethicone 80 mg

Use(s)

 relieves these symptoms associated with gas

  • bloating
  • pressure
  • stuffed feeling
  • fullness
Directions
  •  do not exceed 6 tablets per day unless directed by a doctor
  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
Other Information
  • store at room temperature
  • avoid high humidity and excessive heat, above 40ºC (104ºF) 
Active Ingredients

 Simethicone 80 mg

Inactive Ingredients

 dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

Principal Display Panel

NDC 54868-2860-0

Simethicone 80 mg

Gas Relief

•Pressure   •Bloating   •Discomfort

Fast Acting

Anti Gas

Mind Flavored

100 Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844  REV1104E13712

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

If Pregnant Or Breast Feeding,

 ask a health professional before use.

Structured Label Content

Use(s)

 relieves these symptoms associated with gas

  • bloating
  • pressure
  • stuffed feeling
  • fullness
Purpose

 Antigas

Directions
  •  do not exceed 6 tablets per day unless directed by a doctor
  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
Other Information (Other information)
  • store at room temperature
  • avoid high humidity and excessive heat, above 40ºC (104ºF) 
Active Ingredients (Active ingredients)

 Simethicone 80 mg

Inactive Ingredients (Inactive ingredients)

 dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

Principal Display Panel (Principal display panel)

NDC 54868-2860-0

Simethicone 80 mg

Gas Relief

•Pressure   •Bloating   •Discomfort

Fast Acting

Anti Gas

Mind Flavored

100 Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844  REV1104E13712

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

 ask a health professional before use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:27.177997 · Updated: 2026-03-14T22:53:05.393026