Spongia tosta

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:27:26

Label at a glance#

ProductSpongia tosta
Active ingredientSPONGIA OFFICINALIS SKELETON, ROASTED
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient ** (in each pellet)

Spongia tosta 6C HPUS

(**contains 0.443 mg of the active ingredient per pellet)

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

OTC - PURPOSE SECTION

Relieves croupy, barking, or dry cough and hoarseness*

INDICATIONS & USAGE SECTION

Cough Relief Uses*

temporarily relieves croupy, barking, or dry cough and hoarseness due to minor bronchial irritation

Tube Uses*

Relieves dry, barking cough *

WARNINGS SECTION

Cough Relief Carton

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - STOP USE SECTION

Cough Relief Carton

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Tube

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Cough Relief Carton

Adults and children 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every hour. Decrease frequency with improvement.
Children under 4 years of age: Ask a doctor.

Tube

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

SPL UNCLASSIFIED SECTION

Cough Relief Carton

Cough Relief*

Croupy, Barking or Dry Cough Hoarseness

3 Tubes

Approx 80 pellets each

16 Doses per tube

Total 240 pellets

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Turn tube upside down. Twist until 5 pellets are dispensed. Remove the cap and use it to pour pellets under tongue.

Tube

Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

*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-BOIRON-1
(1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-4866-412023-02-20C16284748780-1f386c649-dfc4-0266-e053-dadaa90a7c1aSpongia tosta 6C
0220-4866-412023-01-30C16284748780-1f386c649-dfc4-0266-e053-dadaa90a7c1aSpongia tosta 6C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-4866-41Spongia tosta6 [hp_C] in 1 TUBEPELLET63
0220-4866-43Spongia tosta3 in 1 BOXPELLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-4866SPONGIA TOSTA (SPONGIA OFFICINALIS SKELETON, ROASTED) PELLET [BOIRON]3Current NDC, Legacy NDC, 2 package rows20240628_86e5946d-2564-e679-e053-2a91aa0ad055.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-48660220-4866-41, 0220-4866-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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
Spongia tostaSPONGIA OFFICINALIS SKELETON, ROASTEDBoiron86e5946d-2564-e679-e053-2a91aa0ad0552024-06-25WarningsExact identifier
ndc (package): 0220-4866-43
ndc (package): 0220-4866-41
ndc (product): 0220-4866
ndc11 (package): 00220486643
ndc11 (package): 00220486641
spl id: 1bbb5859-7692-c1ec-e063-6294a90a9c53
spl set id: 86e5946d-2564-e679-e053-2a91aa0ad055

Reported adverse events (FAERS/openFDA)#

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