Label: WHP BE GONE CONGESTED HEADACHE TM- calcium fluoride - ferrosoferric phosphate - sodium phosphate, dibasic, heptahydrate - sodium chloride pellet

  • NDC Code(s): 68428-747-14, 68428-747-29
  • Packager: Washington Homeopathic Products
  • 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 May 8, 2014

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  • ACTIVE INGREDIENTS

    CALC FLUOR

    FERRUM PHOS

    NAT PHOS

    NAT MUR

  • USES

    Relieves headaches caused by throbbing pain, weakness, and/or dizziness, congested feeling, often stress-related.

  • KEEP OUT OF REACH OF CHILDREN

    As with all medications, keep out of reach of children.

  • INDICATIONS

    Indications:

    Calc fluor 6c –cracking noise*

    Ferrum phos 6c –worse motion*

    Nat phos 6c –throbbing headache*

    Nat mur 6c –blinding headache*

    ■ Weakness* ■ Dizziness* ■ Stress-related*

    *These statements have not been reviewed by the Food and Drug Administration.

  • STOP USE AND ASK DOCTOR

    If symptoms persist or recur, discontinue use. If pregnant or nursing a baby, consult a licensed practitioner before using this product.

  • DIRECTIONS

    Adults: 2 pills every 3 hours for 2 days. Then 2 pills morning and night for 2 weeks.

    Children: 1 pill.

    Repeat as necessary.

  • INACTIVE INGREDIENTS

    Sucrose/Lactose

  • PRINCIPAL DISPLAY PANEL

    image of label

    image of box

  • INGREDIENTS AND APPEARANCE
    WHP BE GONE CONGESTED HEADACHE  TM
    calcium fluoride - ferrosoferric phosphate - sodium phosphate, dibasic, heptahydrate - sodium chloride pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68428-747
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [hp_C]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE6 [hp_C]
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE6 [hp_C]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68428-747-291 in 1 BOX05/08/2014
    1NDC:68428-747-14300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/08/2014
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(68428-747)
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