Label: BHI COLD- pulsatilla vulgaris and sulfur tablet

  • 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 11, 2022

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  • ACTIVE INGREDIENTS

    Each tablet contains: *Pulsatilla 6X, *Sulphur 8X 150 mg each.

    *Natural Ingredients

  • INACTIVE INGREDIENTS

    Inactive Ingredients: **Dextrose, ** Lactose, Magnesium Stearate, **Maltodextrin
    **contains one or more of these ingredients.

  • PURPOSE

    Cold Symptom Relief Tablets

    Relieves:

    • Chills

    • Body Aches

    • Runny Nose

  • USES

    For the temporary relief of minor chills, body aches, runny nose

  • DIRECTIONS

    At first sign of symptoms:

    Adults and children 4 years and older:  1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. 

    Standard dosage:

    Adults and children 4 years and older: Take 1-2 tablets every 4 to 6 hours. Do not exceed 12 tablets in 24 hours. For children under 4, consult your health professional.

    Allow tablets to dissolve completely in the mouth, do not swallow.

  • WARNINGS

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to Cold or any of its ingredients exists.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    BHI Cold Tablet.jpg

  • INGREDIENTS AND APPEARANCE
    BHI COLD 
    pulsatilla vulgaris and sulfur tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code leafman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1023-31 in 1 CARTON08/30/201402/28/2025
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/30/201402/28/2025
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1023)
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