Label: LIPIGESIC M- feverfew and ginger gel 

  • NDC Code(s): 34331-202-06
  • Packager: PuraMed BioScience, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/11

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

  • SPL UNCLASSIFIED SECTION

    What is a Migraine?

    Migraines are classified as “benign headaches” because they are not caused by an underlying medical condition such as a tumor, aneurysm or a similar medical disorder. But, migraine is far from “benign” in terms of its impact on the individual and those around them.

    The pain of a migraine headache is often described as an intense pulsing, throbbing and sometimes disabling pain, which may be limited to one side of the head. It may be accompanied by sensitivity to light and sound, nausea and vomiting.

    There are two major types of migraine headache: classic and common. Classic migraines are often signaled by “aura,” a visual sensory illusion, such as jagged bands of light obscuring vision, or shimmering lights around the edges of objects, before the actual pain begins. Only about 20 percent of sufferers experience aura. Common migraines occur without aura.

    Migraine headaches may result from dietary, environmental and lifestyle triggers. Most migraines are not caused by a single identifiable source, and a person's response to a trigger varies from occurrence to occurrence.

    Migraine Triggers

    DIETARY TRIGGERS

     
    Alcoholic drinks (esp. red wine) Changes in caffeine intake
     
    Aged cheese
     
    Chocolate
     
    Monosodium glutamate (MSG) Nitrates (food preservatives) Yeast
     
    Smoked fish
     
    Nuts
     
    Pickled foods
     
    Missed meals

    ENVIRONMENTAL TRIGGERS

     
    Weather or altitude changes
     
    Bright lights including sunlight
     
    Noise sensitivity
     
    Sensitivity to strong odors
     
    Complex visual patterns
     
    Travel

    LIFESTYLE TRIGGERS

     
    Changes in sleep routine
     
    Overuse of headache medicines
     
    Hormones – women suffer from migraines 3:1 over men
     
    Stress, depression, anxiety, emotions

    What will LipiGesic-M do for me?

    LipiGesic-M is a non-prescription sublingual (under-the-tongue) formulation of natural ingredients used in the early stages of onset to relieve the pain and reduce the associated symptoms of migraine – nausea, vomiting, and sensitivity to light and sound.

    Figure

    In a double-blind placebo controlled study, 64% of headaches resolved with no pain or only mild pain, within 2 hours after LipiGesic-M was taken. (In most cases, relief was experienced prior to the 2-hour- study benchmark.)

    LipiGesic-M is highly effective for the treatment of migraine pain and may cost up to 75% less than the leading prescription migraine medications. Available over-the-counter, LipiGesic-M is the best, first-line defense in the treatment of migraine. Each dose of LipiGesic-M is pre-measured; it is easy to use and easy to transport.

    Who should NOT take LipiGesic-M?

    LipiGesic-M is extremely safe. It can be used by virtually all migraine sufferers.

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  • WARNING:

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

    Also, you should talk to you doctor before using if you have: the worst headache of your life; fever and stiff neck; daily headaches; a headache that is different from your usual migraine; headache that begins after or is caused by head injury, exertion, coughing or bending; experience your first headaches after the age of 50; any continuing medical conditions; migraine headache pain that worsens or continues for more than 48 hours; new or unexpected symptoms.

    If a significant allergic reaction occurs, stop using the product and seek immediate medical help.

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

    What side effects are possible with LipiGesic-M?

    Few side effects have been reported, but may include: body aches, stomach cramps, vomiting, heartburn, nausea and oral numbness.

    What other drugs could interact with LipiGesic-M?

    There are no known drug interactions with LipiGesic-M. However, you should speak with your doctor or pharmacist if you are taking other medications.

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  • DIRECTIONS

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

    • Open one unit dose dispenser by tearing off the perforated end and dispensing entire contents under the tongue.
      Figure

    Important: Hold in place under the tongue for at least 60 seconds; then swallow.

    • Repeat after 5 minutes using a second unit dose dispenser, hold the second dose under the tongue for at least 60 seconds before swallowing.
    • Additional medication may be taken after 30 minutes, either I or 2 unit dose dispensers, as needed or as directed by doctor.
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  • Active Ingredients:

    Feverfew (3X), Ginger (2X)

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  • Other Ingredients:

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

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  • Indication:

    For relief of migraine and associated symptoms.

    Use only if dispenser is intact.

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  • SPL UNCLASSIFIED SECTION

    LipiGesic-M is fast.

    Medications absorbed through the digestive tract generally take up to an hour just to start working, and absorption is highly variable. With the sublingual unit dose system, LipiGesic-M achieves consistent absorption that begins within minutes.

    Figure
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  • SPL UNCLASSIFIED SECTION

    LipiGesic-M is powerful.

    LipiGesic-M's patent-pending formulation, has been shown to be a safe and effective first-line treatment when used at the onset of migraine.* LipiGesic-M is non-habit forming and not associated with rebound headache.

    The active ingredients, Feverfew and Ginger, have had a long history of use and have an excellent safety profile. They have been combined to provide a unique and powerful defense against migraine pain and associated symptoms.

    Results at 2 hours post-dose

    Figure

    After 2 hours, 64% of migraines treated with LipiGesic-M resulted in little or no pain.*

    Figure
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  • It's all in the delivery.

    LipiGesic-M is a patent - pending medication designed to provide fast and effective relief from the pain and associated symptoms of migraine. Unlike typical pills and capsules, LipiGesic-M starts to work almost immediately

    Figure

    Active ingredients are often destroyed when first passing through the stomach or liver – before they have a chance to reach their intended target. Sublingual (under the tongue) administration prevents this “first pass” destruction by delivering the product directly to the bloodstream through the rich network of blood vessels under the tongue. LipiGesic-M's full- strength active ingredients reach the bloodstream faster and more effectively.

    Figure

    The unit dose system is a patent-pending delivery system developed by PuraMed BioScience, and includes the dispenser as well as specific formula enhancements used to improve the sublingual absorption of LipiGesic-M. The unit dose system is an important part of PuraMed's effort to create products that work faster, are more effective and offer better safety profiles than similar products administered by traditional means.

    PuraMed™
    BIOSCIENCE

    Manufactured for
    PuraMed BioScience, Inc. P.O. Box 677, 1326 Schofield Ave. Schofield, WI 54476

    For more information:
    www.LipiGesic.com

    877-851-2190
    info@LipiGesic.com

    © PuraMed BioScience 2011 002-1011-1

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Box Label

    PATENT PENDING HOMEOPATHIC DRUG
    LipiGesic™ M
    Fast Relief for Migraine Pain

    Net Contents 24 ml (.8115 ounces) Unit Dose Dispeners

    Principal Display Panel – Box Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Dose Unit Label

    LipiGesic M
    Migraine
    Headache Pain Reliever

    Principal Display Panel – Dose Unit Label
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  • INGREDIENTS AND APPEARANCE
    LIPIGESIC M 
    feverfew and ginger gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:34331-202
    Route of Administration SUBLINGUAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    feverfew (feverfew) feverfew 3 [hp_X]  in 1 mL
    Ginger (Ginger) Ginger 2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Olive Oil  
    Silicon Dioxide  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor PEPPERMINT (PEPPERMINT) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:34331-202-06 8 in 1 BOX
    1 3 mL in 1 DOSE PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 08/08/2011
    Labeler - PuraMed BioScience, Inc. (627229649)
    Establishment
    Name Address ID/FEI Business Operations
    Hillestad Pharmaceutical 029291085 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Unette Corporation 011401882 PACK
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