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Description
Directions
Ingredients
Warnings
Additional Info
When you're on the go and don't have time to reach for your pain reliever every 4 to 6 hours, try MAXIDOL LIQUID GELS. One pill can provide up to 12 hours of pain relief. With a long-lasting analgesic, MAXIDOL LIQUID GELS provides the lasting relief you've been looking for. EACH LIQUID GEL capsule contains 220 mg Naproxen Sodium.

MAXIDOL LIQUID GELS can provide up to 12 hours of pain relief for:
• Menstrual Cramps
• Muscular ache
• Backache
• Headaches
• Migraine pain


Medicinal ingredient:
Naproxen sodium 220 mg

Non-medicinal ingredients:
FD&C Blue No. 1, gelatin, glycerin, hypromellose, lactic acid, mannitol, polyethylene glycol, povidone, propylene glycol, sorbitan, sorbitol, titanium dioxide and water.


Maxidol contains Naproxen sodium is contraindicated in patients:

- who have previously exhibited allergy or hypersensitivity to to naproxen sodium
- with a history of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/angioedema, nasal polyps, asthma). Fatal anaphylactoid reactions have occurred in such individuals. Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction.
- with active peptic ulcers, a history of recurrent ulceration, or active gastrointestinal bleeding
- with inflammatory bowel disease.
- with severe liver impairment or active liver disease
- with severe renal impairment (creatinine clearance <30 mL/min or 0.5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored)
- in women in their third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and prolonged parturition.

Do not use in children under 12 years. Consult a doctor if fever lasts more than 3 days or pain lasts longer than 5 days or if your symptoms change.

Adults (12-65 years):
1 capsule every 8 - 12 hours.

Adults over 65 years:
1 capsule every 12 hours.

Do not take more than 2 capsules in a 24 hour period. Drink a full glass of water with each dose.

Maxidol contains Naproxen, which like all other nonsteroidal anti-inflammatory drugs (NSAIDs), is an analgesic, antipyretic and anti-inflammatory medication. MAXIDOL® Liquid Gels works at both the site of pain and centrally. The principle mechanism of action relies on the inhibition of prostaglandin synthesis. Prostaglandins are naturally occurring fatty acids derivates that are widely distributed in the tissues in our bodies, and are involved in the production of pain, fever and inflammation. NSAIDs inhibit prostaglandin synthesis through inhibition of the cyclo-oxygenase enzymes. The anti-inflammatory and analgesic activity of these drugs is based on the concept that prostaglandins sensitize the tissues to pain- and inflammation-producing mediators and the antipyretic activity is assumed to be due to inhibition of prostaglandin synthesis in the hypothalamus induced by infectious states such as the common cold.

PRECAUTIONS:

Cardiovascular:
Patients with severe cardiac impairment and a history of hypertension.

Gastrointestinal:
Patients with a medical history of gastrointestinal disease including peptic ulceration. Pain of gastrointestinal origin is not an indication for naproxen sodium.

Hematologic:
Patients with coagulation disturbances. Numerous studies have shown that concomitant use of NSAIDs and anti-coagulants increases the risk of bleeding. Concurrent therapy of MAXIDOL® Liquid Gels with warfarin requires close monitoring of the international normalized ratio (INR). Even with therapeutic INR monitoring, increased bleeding may occur.

Neurologic:
Some patients may experience drowsiness, dizziness, blurred vision vertigo, tinnitus, hearing loss, insomnia or depression with the use of NSAIDs such as MAXIDOL® Liquid Gels. If patients experience such adverse reactions, they should exercise caution in carrying out activities that require alertness, like driving or using machinery.

Respiratory:
Patients with a medical history of asthma, rhinitis or nasal polyps.

Fertility Impairment
Naproxen, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, withdrawal of naproxen should be considered.

Geriatrics:
Patients older than 65 years and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs. The incidence of these adverse reactions increases with dose and duration of
treatment. In addition, these patients are less tolerant to ulceration and bleeding. Most reports of fatal GI events are in this population. Older patients are also at risk of lower esophageal injury including ulceration and bleeding.

Pregnancy:
Caution should be exercised in prescribing MAXIDOL® Liquid Gels during the first and second trimesters of pregnancy. As with other drugs of this type, naproxen sodium produces delay in parturition in animals and also affects the human fetal cardiovascular system (closure of the ductus arteriosus). Therefore, naproxen sodium should not be used unless clearly needed and when directed to do so by a doctor. The use of naproxen sodium in the first and second trimesters of pregnancy requires cautious balancing of the possible benefits and risks to the mother and fetus, especially during the first trimester. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

Nursing Mothers:
Naproxen has been found in the milk of lactating mothers. The use of naproxen sodium should therefore be avoided in women who are breast feeding unless clearly needed and directed to do.

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