H-e-b®

H-e-b®
SPL v3
SPL
SPL Set ID f65e362a-2f90-428a-b885-eefdad8cae1e
Route
ORAL
Published
Effective Date 2025-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (250 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-16
Description

Simethicone 250 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 250 mg

Uses
  • relieves bloating, pressure or fullness commonly referred to as gas
Section 42229-5

Compare to Maximum Strength Phazyme ® active ingredient*

Relieves:

• Bloating

• Pressure

• Fullness

Commonly Referred to as Gas

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

MADE WITH PRIDE AND CARE FOR H-E-B®,

SAN ANTONIO, TEXAS 78204

Product of United Arab Emirates

100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

*Phazyme® is a registered trademark of C.B. Fleet Company Inc.

Section 50565-1

Keep out of reach of children.

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions
  • Swallow one or two softgels as symptoms occur
  • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician
Drug Facts

Other Information
  • store at room temperature 20-25°C (68-77°F)
  • protect from heat, humidity and light
Inactive Ingredients

D&C Red #33, edible ink, FD&C Blue #1, gelatin, glycerin, purified water

Questions Or Comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel)

Simethicone 250 mg

Structured Label Content

Uses
  • relieves bloating, pressure or fullness commonly referred to as gas
Section 42229-5 (42229-5)

Compare to Maximum Strength Phazyme ® active ingredient*

Relieves:

• Bloating

• Pressure

• Fullness

Commonly Referred to as Gas

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

MADE WITH PRIDE AND CARE FOR H-E-B®,

SAN ANTONIO, TEXAS 78204

Product of United Arab Emirates

100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

*Phazyme® is a registered trademark of C.B. Fleet Company Inc.

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Anti-gas

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions
  • Swallow one or two softgels as symptoms occur
  • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician
Drug Facts

Other Information (Other information)
  • store at room temperature 20-25°C (68-77°F)
  • protect from heat, humidity and light
Inactive Ingredients (Inactive ingredients)

D&C Red #33, edible ink, FD&C Blue #1, gelatin, glycerin, purified water

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 250 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.327460 · Updated: 2026-03-14T23:06:45.911086