FDA.reportPublic FDA data

GASALIA

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:22:28

Label at a glance#

ProductGASALIA
Active ingredientRADISH, LYCOPODIUM CLAVATUM SPORE, ACTIVATED CHARCOAL, NUTMEG
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each pellet)

Carbo vegetabilis 6C HPUS (0.11 mg)

Lycopodium clavatum 6C HPUS (0.11 mg)

Nux Moschata 6C HPUS (0.11 mg)

Raphanus sativus 6C HPUS (0.11 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Carbo Vegetabilis 6C HPUS (0.11 mg) ... Relieves stomach bloating with gas

Lycopodium clavatum 6C HPUS (0.11 mg) ... Relieves bloated lower abdomen

Nux moschata 6C HPUS (0.11 mg) ... Relieves abdominal bloating accompanied by constipation

Raphanus sativus 6C HPUS (0.11 mg) ... Relieves abdominal pain and bloating with difficulty passing gas

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves bloating, pressure, discomfort, and pain commonly referred to as gas

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every hour until symptoms are relieved. If necessary, dissolve 5 pellets under the tongue 15 minutes before meals.
  • Children under 6 years of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

SPL UNCLASSIFIED SECTION

  • do not use if glue carton end flaps are open if pellet dispenser seal is broken
  • contains 0.25 g of sugar per pose

Multi-Symptom

Gas & Bloating Relief*

Plant-Powered Relief

Meltaway Pellets

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Contains approx. 80 pellets, 3.8 g (0.13 oz)

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

Do not use if pellet dispenser seal is broken.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Distributed by

Boiron, Inc.

Newtown Square, PA

19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabelslabels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9135-41GASALIA80 in 1 TUBEPELLET802
0220-9135-42GASALIA2 in 1 BOXPELLET22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9135GASALIA (ACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, NUTMEG, RADISH) PELLET [BOIRON]2Current NDC, Legacy NDC, 2 package rows20231005_de99ffbf-cb1d-80bf-e053-2a95a90ac99d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-91350220-9135-41, 0220-9135-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SUCROSEC151H8M554IACT
RADISHEM5RP35463ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
NUTMEGAEE24M3MQ9ACTIB

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
GASALIAACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, NUTMEG, RADISHBoironde99ffbf-cb1d-80bf-e053-2a95a90ac99d2023-10-04Exact identifier
ndc (package): 0220-9135-42
ndc (package): 0220-9135-41
ndc (product): 0220-9135
ndc11 (package): 00220913542
ndc11 (package): 00220913541
spl id: 06ea4a82-ecad-6320-e063-6394a90ab9a0
spl set id: de99ffbf-cb1d-80bf-e053-2a95a90ac99d

Reported adverse events (FAERS/openFDA)#

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