Active Ingredient(S)
Anise Dry Extract 2%
Dry Fennel Extract 2%
Digestion-bloating-gas
FDA Label NDC 79394-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L'envol Pharma for the product Digestion-bloating-gas (NDC 79394-000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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.
Otc - Stop Use
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
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
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