Label: SPONGIA TOSTA- spongia officinalis skeleton, roasted pellet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 25, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    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.

  • PURPOSE

    Relieves croupy, barking, or dry cough and hoarseness*

  • INDICATIONS & USAGE

    Cough Relief Uses*

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

    Tube Uses*

    Relieves dry, barking cough *

  • WARNINGS

    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
  • STOP USE

    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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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

    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.

  • QUESTIONS

    BoironUSA.com Info@boiron.com
    1-800-BOIRON-1
    (1-800-264-7661)
    Distributed by Boiron, Inc.
    Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    labellabellabel

  • INGREDIENTS AND APPEARANCE
    SPONGIA TOSTA 
    spongia officinalis skeleton, roasted pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-4866
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_C]  in 6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-4866-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-4866-433 in 1 BOX06/25/2024
    2NDC:0220-4866-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-4866)