Digestion-Bloating-Gas

Manufacturer
L'ENVOL PHARMA
Effective date
2020-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:33

Label at a glance#

ProductDigestion-Bloating-Gas
Active ingredientFENNEL, ANISE OIL
Label structure12 sections

Dosage and administration

Take 1 tablet 3-4 times a day. Children under 12 years of age should not use product

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Anise Dry Extract 2%

Dry Fennel Extract 2%

Purpose

OTC - PURPOSE SECTION

Light and Ease of Digestion

Use

INDICATIONS & USAGE SECTION

Take 1 tablet 3-4 times a day when having issues with digestion

Warnings

WARNINGS SECTION

No more than 6 tablets in a day.

Keep away from children

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If any issues occur get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take 1 tablet 3-4 times a day.
  • Children under 12 years of age should not use product

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium stearate, non-hydrogenated vegetable oil, Menthol, Star Asine essential oil,Stevia Powder

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16 U NDC: 79394-000-01

ll

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79394-000-012022-01-28C16284748780-1d6a99b39-5d2e-a426-e053-dadaa90af4c2ab0ec1dc-060f-f27f-e053-2a95a90a3782

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79394-000-01Digestion-Bloating-Gas24000 mg in 1 DOSE PACKPILL240001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79394-000DIGESTION-BLOATING-GAS (TRIPLEX) PILL [L'ENVOL PHARMA]1Legacy NDC, 1 package rows20200725_ab0ec1dc-060f-f27f-e053-2a95a90a3782.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79394-00079394-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
ab0ec1dc-0601-f27f-e053-2a95a90a3782ab0ec1dc-060f-f27f-e053-2a95a90a37822020-07-22WarningsExact identifier
spl id: ab0ec1dc-0601-f27f-e053-2a95a90a3782
spl set id: ab0ec1dc-060f-f27f-e053-2a95a90a3782

Reported adverse events (FAERS/openFDA)#

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