Label: DIARALIA- arsenic trioxide, cinchona officinalis bark, podophyllum pellet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 October 4, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Arsenicum album 9C HPUS (0.15 mg) (contains less than 10 -18 mg arsenic)

    Cinchona officinalis 5C HPUS (0.15 mg)

    Podophyllum peltatum 9C HPUS (0.15 mg)

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

  • PURPOSE

    Purpose*

    ​Arsenicum album 9C HPUS (0.15 mg) .... Relieves diarrhea with nausea, vomiting, and weakness

    Cinchona officinalis 5C HPUS (0.15 mg) ... Relieves diarrhea with gas and bloating

    Podophyllum peltatum 9C HPUS (0.15 mg) ... Relieves diarrhea with intestinal rumbling and pain

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves symptoms of diarrhea such as:

    • traveler's diarrhea
    • intestinal pain
    • bloating
    • gas
    • nausea
    • vomiting
  • WARNINGS

  • ASK DOCTOR

    Ask a doctor before us if you have

    • fever
    • bloody or black stool
    • mucus in your stool.
  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 2 days or worsen.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Drink plenty of clear fluids to help prevent dehydration cause by diarrhea.

    • Adults and children 6 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 4 to 6 hours, up to 2 days maximum. Discontinue use as soon as symptoms disappear.
    • Children under 6 years of age: Ask a doctor.

  • SPL UNCLASSIFIED SECTION

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

    Multi-symptom Diarrhea Relief*

    Bloating, Nausea & Vomiting*

    Meltaway Pellets

    2 PORTABLE TUBES

    APPROX. 80 PELLETS EACH

    TOTAL 160 PELLETS

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

    Do not use if pellet dispenser seal is broken.

    Turn tube upside down

    Twist until 5 pellets are dispensed

    Remove cap and pour pellets under the tongue

    Turn tube upside down & twist cap

    *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.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • QUESTIONS

    1-800-264-7661

    Made in France
    Distributed by Boiron, Inc.
    Newtown Square, PA
    ​19073

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    DIARALIA 
    arsenic trioxide, cinchona officinalis bark, podophyllum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9097
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM9 [hp_C]
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK5 [hp_C]
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE9 [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:0220-9097-422 in 1 BOX05/09/2022
    1NDC:0220-9097-4180 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2022
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9097)