Your browser does not support JavaScript! LIPIGESIC M (FEVERFEW AND GINGER) GEL [PURAMED BIOSCIENCE, INC.]
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LIPIGESIC M (feverfew and ginger) gel
[PuraMed BioScience, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved homeopathic
NOTE: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 Sections

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.

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.

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.

Active Ingredients:

Feverfew (3X), Ginger (2X)

Other Ingredients:

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

Indication:

For relief of migraine and associated symptoms.

Use only if dispenser is intact.

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

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

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

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

Principal Display Panel – Dose Unit Label

LipiGesic M
Migraine
Headache Pain Reliever

Principal Display Panel – Dose Unit Label
LIPIGESIC M 
feverfew and ginger gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:34331-202
Route of AdministrationSUBLINGUALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
feverfew (feverfew) feverfew3 [hp_X]  in 1 mL
Ginger (Ginger) Ginger2 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Olive Oil 
Silicon Dioxide 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINT (PEPPERMINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34331-202-068 in 1 BOX
13 mL in 1 DOSE PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/08/2011
Labeler - PuraMed BioScience, Inc. (627229649)
Establishment
NameAddressID/FEIBusiness Operations
Hillestad Pharmaceutical029291085MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Unette Corporation011401882PACK

Revised: 12/2011
 
PuraMed BioScience, Inc.

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