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Medique Mediproxen


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Naproxen Sodium 220 mg (Naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug


OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer


INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to

temporarily reduces fever

  • minor pain of arthritis
  • muscular aches
  • backache
  • menstrual cramps
  • headache
  • toothache
  • the common cold

WARNINGS SECTION

Warnings

Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Heart attack and stroke warning:

NSAID, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

OTC - DO NOT USE SECTION

Do not use

  • if you ever have had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have a history of stomach problems such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

■ you are taking a diuretic

■ you have problems or serious side effects from taking pain relievers or fever reducers


OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better

■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ you have difficulty swallowing

■ it feels like the pill is stuck in your throat

■ redness or swelling is present in the painful area

■ any new symptoms appear


OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.


DOSAGE & ADMINISTRATION SECTION

Directions

Adults: (12 years of age and older)

Children under 12 years: ask a doctor

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: sodium 20 mg
  • store at 68-77ºF (20-25ºC)
  • avoid high humidity and excessive heat above 104ºF (40ºC)
  • tamper evident sealed packets
  • do not use any open or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide


OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique®

Mediproxen

Long-Lasting Pain Relief

This Package is for Households without Small Children

Pull to Open

Pain, Fever • Naproxen Sodium USP, 220 mg (NSAID)

50 Tablets

(50 x 1)

Tamper Evident Unit Dose Packets