Label: MIGRAPURE- feverfew and ginger gel

  • 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 December 12, 2014

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

  • PATIENT PACKAGE INSERT

    Clinical tests1 show that MigraPure provides advanced migraine pain relief

    MigraPure's advanced formula is a first-line treatment for acute migraine pain.

    MigraPure also relieves symptoms often associated with migraine.

    With an excellent safety profile, MigraPure can be used by virtually all migraine sufferers.Figure
Figure

    MigraPure was originally tested as LipiGesic M, Patent #8,409,637

    [1] Cady, RK, Goldstein J, Nett R, et al. A double-blind placebo-controlled pilot study of sublingual feverfew and ginger (LipiGesic™ M) in the treatment of migraine.

    MigraPure absorbs under-the-tongue for fast results

    Figure

    MigraPure's patented delivery system is different than traditional medications.

    Simply squeeze the contents of MigraPure's pre-measured UnitDose sachet under your tongue and hold it there for one minute.

    MigraPure's full-strength feverfew and ginger gel absorbs directly into your bloodstream through he capillaries under your tongue. MigraPure starts to work immediately for ultra-fast relief.

    Pill and capsules often lose 50 to 75 percent of their potency as they travel through the stomach and liver. It may take over an hour for relief.

    “After not having any luck with even prescription medications, I decided to try it. Within seconds after putting it in my mouth, the migraines dissipate. Within a few minutes, the migraines disappear completely. “Stopping dead in it's tracks” is an understatement. I finally have gotten some relief. As great as this works, I would pay triple for. Thank you for such an incredible product. ~Garrett D

    Does MigraPure cause side effects?

    No serious adverse events were reported1. The few side effects recorded included body aches, stomach cramps, vomiting, oral tingling or numbness, heartburn and nausea.

    What drugs interact with MigraPure?

    There are no reported drug interactions with MigraPure. However, you should consult your healthcare provider if you are taking other medications.

    Who should NOT take MigraPure?

    Warning: If pregnant or breastfeeding, ask a healthcare professional before use.

    Do not use if you have a known allergy or hypersensitivity to ragweed or other members of the Asteraceae family or any other ingredient. If a significant allergic reaction occurs, stop using the product and seek immediate medical help.

    Ask a healthcare profession before use if:

    • You are under a doctor's care for any continuing medical condition
    • You experienced your first headaches after the age of 50
    • Your headache lasts more than 48 hours
    • You have a headache that is different from your usual migraine
    • Your headache begins after head injury, exertion coughing or bending
    • New or unexpected symptoms occur
    • You have a fever and stiff neck
    • You have the worst headache of your life
    • You have daily headaches

    DIRECTIONS

    For maximum effectiveness, begin treatment at the first sign of headache.

    Open one UnitDose dispenser by tearing off the perforated end and dispensing entire contents under the tongue. Important: Hold in place under the tongue for at least 60 seconds; then, swallow.

    Repeat with second UnitDose after 5 minutes.

    For maximum effectiveness: Don't eat or drink anything for at least 15 minutes after taking a UnitDose.

    If needed or as directed by a doctor, an additional 1 or 2 UnitDose dispensers may be taken after 30 minutes.

    Active Ingredients: Pyrethrum Parthenium [Feverfew] (3X), Zingiber Officinale [Ginger] (2X)

    Other Ingredients: N.F. Grade Olive Oil, Silicon Dioxide, Peppermint Flavor

    Indication: For relief of migraine and associated symptoms and migraine-like headaches such as sinus and hangover headaches.

    Use only if UnitDose dispenser is intact.

    __________________________

    [2] Cady, RJ, Shade, CL, Cady RK. Advances in Drug Development for Acute Migraine.

    Please keep this and all dugs out of the reach of children.

    MigraPure is effective

    • Doctor recommended, clinical tested homeopathic medication
    • All-natural feverfew and ginger gel
    • Safer than other over the counter or RX medications
    • Non-drowsy, non-habit-forming
    • Easy-to-use, FAST

    MigraPure is unique

    Figure

    MigraPure is a homeopathic gel taken under the tongue. Full-strength active ingredients absorb directly into the blood stream to reach pain faster. Clinical trials show it is effective for 64 percent of migraines – at a fraction of the cost of prescriptions. MigraPure does not contain acetaminophen, aspirin, or caffeine or other chemical compounds.

    “Advantages of this product include lower cost, OTC availability and it is not likely to produce medication-overuse headache. It is an excellent first-line therapy for very early intervention, as it is compatible with other acute treatment options.”

    ~ Roger K Cady, MD Headache expert and founder of the Headache Care Center

    Cady RJ, Shade CL, Cady RK. Advances in Drug Development for Acute Migraine. Drugs 2012; 72 (17): 2187-2205

    MigraPure is TOUGH on migraine and migraine-like headache, but easy on you

    MigraPure's all natural formula is non-drowsy, non-habit forming and causes less stomach upset than convention migraine treatments.

    MigraPure is easy to carry and easy to use. It is pre-measured so you can take it anywhere. You don't even need water.

    MigraPure is easy on your wallet. MigraPure gives you the power of prescription strength in an over-the-counter formula, without the severe side effects and without the high cost.

    MigraPure costs up to 75 percent less than the top-selling prescription migraine medication.

    What are migraine-like headaches?

    There are other types of headache pain that mimic migraine and can be successfully treated by MigraPure.

    Hangover: The same type of pain-causing chemical cascade happens during a migraine that happens during a hangover. People have used MigraPure successfully to treat hangovers. The benefit of using MigraPure is that it does not have a negative impact on the liver.

    Sinus pain: According to the American Migraine Study II, 9 out of 10 self-diagnosed sinus headaches are actually migraines. Migraines can cause pain and pressure in the forehead and sinus area.

    A sinus headache, however, is accompanied by signs of infection such as discolored nasal discharge.

    Migraines can last 4 to 72 hours – the pain doesn't have to.

    Thank you for trying MigraPure.

    If this is your first time trying our product, we would like to hear from you.

    Send us your story and give us permission to use your MigraPure story as a testimonial, and we will send you a free box of MigraPure. (We'll only publish your first name, city and state.)

    Contact us by email:

    story@MigraPure.com

    Contact us via our website:

    www.MigraPure. com/story

    Or send a letter to:

    1326 Schofield Avenue

    Schofield, WI 54476

    Just be sure to tell us we have permission to use your story.

    Your privacy is important to us. We will not share or sell your information.

    PuraMed®

    BioScience

    Manufactured for
    PuraMed BioScience, Inc.
    P.O. Box 677, Schofield, WI 54476

    www.MigraPure.com
    877-851-2190 info@MigraPure.com

    © PuraMed BioScience, Inc.® 2014

    0215

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredients

    Feverfew (3X), Ginger (2X)

  • Purpose

    Relief of migraine pain and associated symptoms and migraine-like headaches such as sinus and hangover headache

  • Uses

    Use at the first sign of migraine or migraine-like headache

  • Warnings

  • PREGNANCY OR BREAST FEEDING

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

    Do not use if you have a known allergy or hypersensitivity to ragweed or other members of the Asteraceae family or any other ingredient. If a significant allergic reaction occurs, stop using the product and seek immediate medical help.

    Keep this and all drugs out of the reach of children.

    Ask a doctor or pharmacist before use if

    • you are under a doctor's care for any continuing medical condition
    • you experienced your first headaches after the age of 50
    • your headache lasts more than 48 hours
    • you have a headache that is different from your usual migraine
    • your headache begins after head injury, exertion, coughing or bending
    • new or unexpected symptoms occur
    • you have the worst headache of your life
    • you have fever and stiff neck
    • you have daily headaches
  • Directions

    To open UnitDose dispenser, tear off the perforated end. Squeeze entire contents under the tongue.

    • Important: Hold gel under the tongue for 60 seconds, then swallow.
    • Repeat after 5 minutes using a second UnitDose dispenser.

      Avoid eating or drinking liquids for 15 minutes after each dose.

    • An additional dose may be taken after 30 minutes. Take 1 or 2 UnitDose dispensers, as needed or as directed by a doctor
  • Other information

    Store at 20 - 60° C (68 - 120° F)

  • Inactive ingredients

    N.F. Grade Olive Oil, Silicon Dioxide, Peppermint Flavor

  • Principal Display Panel - 3mL Carton Label

    MigraPureTM

    Advanced migraine relief

    Applied under the tongue

    so it can start working

    in minutes*

    HOMEOPATHIC DRUG

    Feverfew and Ginger Gel

    Net Contents 12 ml (.4056 ounces)

    4 3ml (.1014 ounce) UnitDose Dispensers

    Principal Display Panel - 3mL Carton Label
  • INGREDIENTS AND APPEARANCE
    MIGRAPURE 
    feverfew and ginger gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34331-302
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    feverfew (UNII: Z64FK7P217) (feverfew - UNII:Z64FK7P217) feverfew3 [hp_X]  in 1 mL
    Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Olive Oil (UNII: 6UYK2W1W1E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINT (PEPPERMINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34331-302-044 in 1 BOX
    13 mL in 1 DOSE PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2015
    Labeler - PuraMed BioScience, Inc. (627229649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hillestad Pharmaceuticals029291085MANUFACTURE(34331-302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unette Corporation011401882MANUFACTURE(34331-302) , PACK(34331-302) , LABEL(34331-302)