DIGESTION-BLOATING-GAS- triplex pill

Digestion-Bloating-Gas by

Drug Labeling and Warnings

Digestion-Bloating-Gas by is a Otc medication manufactured, distributed, or labeled by L'ENVOL PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Anise Dry Extract 2%

Dry Fennel Extract 2%

Purpose

Light and Ease of Digestion

Use

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

Warnings

No more than 6 tablets in a day.

Keep away from children

Do not use

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

WHEN USING

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.

STOP USE

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

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

Directions

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

Other information

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

Inactive ingredients

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

Package Label - Principal Display Panel

16 U NDC: 79394-000-01

INGREDIENTS AND APPEARANCE

DIGESTION-BLOATING-GAS 
triplex pill

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79394-000
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3)	FENNEL	2 mg  in 100 mg
ANISE OIL (UNII: 6Y89129C8H) (ANISE OIL - UNII:6Y89129C8H)	ANISE OIL	2 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
STAR ANISE OIL (UNII: 6RXP35EIRE)
STEVIA LEAF (UNII: 6TC6NN0876)
MENTHOL (UNII: L7T10EIP3A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	2mm
Flavor	ANISE	Imprint Code	TX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79394-000-01	24000 mg in 1 DOSE PACK; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020

Labeler - L'ENVOL PHARMA (362865293)

Registrant - L'ENVOL PHARMA (362865293)

Establishment
Name	Address	ID/FEI	Business Operations
L'ENVOL PHARMA		362865293	manufacture(79394-000)