Label: PULSATILLA- anemone pulsatilla 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 January 12, 2023

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

  • ACTIVE INGREDIENT

    Tube - Pulsatilla 30C (**contains 0.443 mg of the active ingredient per pellet)

    Box - Pulsatilla 30C HPUS (**contains 0.443 mg of the active ingredient in each pellet)

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

  • PURPOSE

    Box - Relieves cold symptoms including thick, yellow nasal discharge*

  • INDICATIONS & USAGE

    Tube - Cold With Thick Yellow Discharge*

    Box - temporarily relieves cold symptoms such as: nasal congestion, think, yellow nasal mucus, spasmodic, wet cough, loss of taste or smell*

  • WARNINGS

  • DO NOT USE

    Box - Do not use for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

  • STOP USE

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

    Box - Stop use and ask a doctor if symptoms persist for more than 3 days, comes back, or is accompanied by fever, rash, or persistent headache, as these could be signs of a serious conditions.

  • PREGNANCY OR BREAST FEEDING

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

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

  • KEEP OUT OF REACH OF CHILDREN

    Tube - Keep out of reach of children.

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

  • SPL UNCLASSIFIED SECTION

    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.

    Box - Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.

    3 Tubes approx 80 pellets 16 Doses per tube Total 240 pellets

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

    No known drug interactions

    Non-drowsy

    Meltaway Pellets

    Cough & Mucus Relief*

    Nasal Congestion Thick Mucus Cough*
    *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

    Tube - lactose, sucrose

    Box - lactose, sucrose

  • DOSAGE & ADMINISTRATION

    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.

    Box - 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.

  • 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

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    PULSATILLA 
    anemone pulsatilla pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-4185
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]  in 30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-4185-4130 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-4185-433 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(0220-4185)