FDA.reportPublic FDA data

a+ health-simethicone capsules 500 mg dye free

Manufacturer
BIONPHARMA INC. | Ocean Healthcare Pvt Ltd
Effective date
2026-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-02 01:04:43

Label at a glance#

Productgas relief
Active ingredientDIMETHICONE
Label structure13 sections

Indications and uses

relieves bloating, pressure, fullness, commonly referred to as gas.

Dosage and administration

■ adults and children 12 years and older: swallow with water 1 capsule after meals or at bedtime ■ do not exceed 1 capsule in 24 hours except under the advice and supervision of a physician

Storage and handling

■ store at 20°-25°C (68°-77°F) ■ protect from light, heat and moisture.

Label contents#

Full prescribing information#

Active ingredient (in each capsules)

OTC - ACTIVE INGREDIENT SECTION

Simethicone USP, 500 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure, fullness, commonly referred to as gas.

WARNINGS SECTION

Warnings

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

condition persists.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION


■ adults and children 12 years and older:
swallow with water 1 capsule after meals or at bedtime
■ do not exceed 1 capsule in 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

■ store at 20°-25°C (68°-77°F)
■ protect from light, heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, pharmaceutical ink, purified water, sorbitol

Questions?

OTC - QUESTIONS SECTION

call 1-888-235-2466

SPL UNCLASSIFIED SECTION

***This product is not manufactured or distributed by the owner of the registered trademark Gas-X® Ultimate Strength.

Manufactured for:
BIONPHARMA
Princeton, NJ 08540
MADE IN INDIA

NDC 69452-581-24

Code:TN/Drugs/TN00003701

PMP01871

L0001315 R0826

500 mg label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

***compare to the active ingredient in
Gas-X® UltimateStrength

a+ health

ultimate strength

gas relief

simethicone capsules USP, 500 mg

antigas

relieves: ● bloating ● pressure
● fullness ● discomfort

150 SOFTGELS**

**liquid-filled capsules

bottle-labelbottle-label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-58169452-581-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
GLYCERINPDC6A3C0OXIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsName fallback
generic name: DIMETHICONE
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsName fallback
generic name: DIMETHICONE
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsName fallback
generic name: DIMETHICONE
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsName fallback
generic name: DIMETHICONE
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsName fallback
generic name: DIMETHICONE
Gas ReliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI011859d8-3d0f-4ca7-a98b-4150054154dc2026-09-01WarningsName fallback
brand name: Gas Relief
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsName fallback
generic name: DIMETHICONE
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsName fallback
brand name: Gas Relief
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsName fallback
generic name: DIMETHICONE
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsName fallback
generic name: DIMETHICONE
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsName fallback
generic name: DIMETHICONE
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsName fallback
generic name: DIMETHICONE
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsName fallback
generic name: DIMETHICONE
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsName fallback
brand name: Gas Relief

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.