Label: ARSENICUM ALBUM- arsenic trioxide 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 July 26, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)


    Box - Arsenicum album 30C HPUS (0.44 mg)(contains less than 10 -12 mg arsenic)

    Tube - Arsenicum album 30C HPUS (**contains 0.443 mg of the active ingredient per pellet) (contains less than 10 -12 mg arsenic)

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

  • PURPOSE

    Purpose*

    Box - Relieves diarrhea with vomiting and weakness

  • INDICATIONS & USAGE

    Uses*

    Box - temporarily relieves symptoms of diarrhea including: nausea, vomiting, cramps, weakness with chills, traveler's diarrhea

    Tube - Diarrhea With Vomiting And Weakness*

  • WARNINGS

  • DO NOT USE

    Box - Do not use if you have: bloody or black stool.

  • ASK DOCTOR

    Box - As a doctor before using if you have: fever, mucus in stool

  • STOP USE

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

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

  • PREGNANCY OR BREAST FEEDING

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

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

  • KEEP OUT OF REACH OF CHILDREN

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

    Tube - Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Box - Drink plenty of clear fluids to help prevent dehydration caused by diarrhea. 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.

    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

    Box - lactose, sucrose

    Tube - lactose, sucrose

  • QUESTIONS

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

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

  • SPL UNCLASSIFIED SECTION

    Box - 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

    3 Tubes

    Approx. 80 pellets each

    Total 240 pellets

    16 Doses per tube

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

    Diarrhea & Vomiting Relief*

    Nausea Cramps Weakness*

    Multi-Symptom Relief

    Non-drowsy

    Meltaway Pellets
    *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.

    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.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ARSENICUM ALBUM 
    arsenic trioxide pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-0530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_C]  in 30 [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:0220-0530-4130 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-0530-433 in 1 BOX09/01/2020
    230 [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(0220-0530)