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.
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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.
- Alcoholic drinks (esp. red wine) Changes in caffeine intake
- Aged cheese
- Monosodium glutamate (MSG) Nitrates (food preservatives) Yeast
- Smoked fish
- Pickled foods
- Missed meals
- Weather or altitude changes
- Bright lights including sunlight
- Noise sensitivity
- Sensitivity to strong odors
- Complex visual patterns
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.
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.
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.
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.
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.
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)Close
- Other Ingredients:
N.F. Grade Olive Oil, Silicon Dioxide, Peppermint FlavorClose
For relief of migraine and associated symptoms.
Use only if dispenser is intact.Close
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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.Close
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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
After 2 hours, 64% of migraines treated with LipiGesic-M resulted in little or no pain.*
- 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
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.
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, Inc. P.O. Box 677, 1326 Schofield Ave. Schofield, WI 54476
For more information:
© PuraMed BioScience 2011 002-1011-1Close
- PRINCIPAL DISPLAY PANEL
Principal Display Panel – Box Label
PATENT PENDING HOMEOPATHIC DRUG
Fast Relief for Migraine Pain
Net Contents 24 ml (.8115 ounces) Unit Dose DispenersClose
- PRINCIPAL DISPLAY PANEL
Principal Display Panel – Dose Unit Label
Headache Pain Reliever
- INGREDIENTS AND APPEARANCE
feverfew and ginger gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34331-202 Route of Administration SUBLINGUAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength feverfew (UNII: Z64FK7P217) (feverfew - UNII:Z64FK7P217) feverfew 3 [hp_X] in 1 mL Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger 2 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Olive Oil (UNII: 6UYK2W1W1E) Silicon Dioxide (UNII: ETJ7Z6XBU4) 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