LipiGesic M

Manufacturer
PuraMed BioScience, Inc. | Hillestad Pharmaceutical | Unette Corporation
Effective date
2011-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:50:12

Label at a glance#

ProductLipiGesic M
Active ingredientfeverfew, Ginger
Label structure11 sections

Dosage and administration

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 me...

Label contents#

Full prescribing information#

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

SPL UNCLASSIFIED SECTION

DIETARY TRIGGERS

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

  • 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?

OTC - PURPOSE SECTION

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
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?

SPL UNCLASSIFIED SECTION

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

WARNING:

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

What side effects are possible with LipiGesic-M?

ADVERSE REACTIONS SECTION

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?

DRUG INTERACTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.FigureFigure

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:

OTC - ACTIVE INGREDIENT SECTION

Feverfew (3X), Ginger (2X)

Other Ingredients:

INACTIVE INGREDIENT SECTION

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

Indication:

INDICATIONS & USAGE SECTION

For relief of migraine and associated symptoms.

Use only if dispenser is intact.

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
Figure

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

SPL UNCLASSIFIED SECTION

Figure
Figure

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

Figure
Figure

It's all in the delivery.

SPL UNCLASSIFIED SECTION

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
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
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

PACKAGE LABEL.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
Principal Display Panel – Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Dose Unit Label

LipiGesic M
Migraine
Headache Pain Reliever

Principal Display Panel – Dose Unit Label
Principal Display Panel – Dose Unit Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
34331-202-062025-01-06C16284748780-197449f38-bf12-f6ea-e053-dbdaa90aa703db04a14c-b6b7-4f81-be84-55052e6ed70a
34331-202-062019-11-13C16284748780-197449f38-bf12-f6ea-e053-dbdaa90aa703db04a14c-b6b7-4f81-be84-55052e6ed70a

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
feverfewACTIVE INGREDIENTZ64FK7P2172
GingerACTIVE INGREDIENTC5529G5JPQ2
feverfewACTIVE MOIETYZ64FK7P2172
GingerACTIVE MOIETYC5529G5JPQ2
Olive OilINACTIVE INGREDIENT6UYK2W1W1E2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU42

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34331-20234331-202-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
feverfewZ64FK7P217ACTIB
GingerC5529G5JPQACTIB
Olive Oil6UYK2W1W1EIACT
Silicon DioxideETJ7Z6XBU4IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 54 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
Olive OilOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
Olive OilOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
Olive OilOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
Olive OilOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
Olive OilOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b105ec3-4082-dc4d-e063-6394a90a340ddb04a14c-b6b7-4f81-be84-55052e6ed70a2025-01-06Warnings, Adverse reactionsExact identifier
spl set id: db04a14c-b6b7-4f81-be84-55052e6ed70a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.