FDA.reportPublic FDA data

Firstcare Maximum Strength Gas Relief Simethicone 250 mg Anti-gas

Manufacturer
USpharma Ltd
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:49:04

Label at a glance#

ProductFirstcare Maximum Strength Gas Relief Simethicone 250 mg Anti-gas
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime. do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.

Label contents#

Full prescribing information#

Active ingredient (in each chewable)

OTC - ACTIVE INGREDIENT SECTION

Simethicone, 250 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
  • do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.

Other information

SPL UNCLASSIFIED SECTION

  • each chewable contains  sodium 5 mg. very low sodium
  • store at controlled room temperature 20-25°C (68-77°F).
  • protect from light, heat and moisture.
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

carnauba wax, citric acid, croscarmellose sodium, crospovidone, FD&C red #40, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-227-6151

SPL UNCLASSIFIED SECTION

USpharma

13900 NW 57th Court, Miami Lakes, FL 33014

1-800-227-6151 www.uspharmaltd.com

Principal display Panel-250 mg bottle label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FIRSTCARE

MADE IN USA

NDC 71594-707-08

MAXIMUM STRENGTH

GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

Fast Relief of:

Bloating, Pressure,
Gas discomfort

Mixed Berry Flavor

20 SOFT CHEWABLES

Principal display Panel-250 mg bottle labelPrincipal display Panel-250 mg bottle label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71594-707FIRSTCARE MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 MG ANTI-GAS (SIMETHICONE) TABLET, CHEWABLE [USPHARMA LTD]2Unmatched20241122_fa8cf730-19b3-4354-bc50-68a6f877c981.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71594-70771594-707-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
FD&C RED NO. 40WZB9127XOAIACT
CORN SYRUP9G5L16BK6NIACT
GLYCERINPDC6A3C0OXIACT
ACACIA5C5403N26OIACT
MALTITOLD65DG142WKIACT
MANNITOL3OWL53L36AIACT
MILK PROTEIN CONCENTRATE871QYF3I7BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
DIMETHICONE92RU3N3Y1OACTIB

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4654a73d-1d66-2fe4-e063-6394a90a4189fa8cf730-19b3-4354-bc50-68a6f877c9812025-12-19WarningsExact identifier
spl set id: fa8cf730-19b3-4354-bc50-68a6f877c981

Reported adverse events (FAERS/openFDA)#

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