Medique Mediproxen

Medique Mediproxen
SPL v1
SPL
SPL Set ID f01adfcc-b32a-4a98-a4e7-2ce87b824b5a
Route
ORAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Croscarmellose Sodium Fd&c Blue No. 2 Magnesium Stearate Polyvinyl Alcohol Povidone Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: I;3 Shape: round Color: blue Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2008-12-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

Symptoms may include:

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

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:

  • are age 60 or older
  • have stomach ulcers or bleeding problems
  • take a blood thinner (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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.

Indications and Usage

Uses

temporarily relieves minor aches and pains due to

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

temporarily reduces fever

Dosage and Administration

Directions

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

Adults: (12 years of age and older)

  • take 1 tablet every 8 to 12 hours while symptoms last.
  • for the first dose you may take 2 tablets within the first hour.
  • do not exceed 2 tablets in any 8 to 12 hour period
  • do not exceed 3 tablets in a 24 hour period

Children under 12 years:ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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

Section 50567-7

When using this product

  • take with food or milk if stomach upset occurs
Section 50568-5

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
Section 50569-3

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

Section 50570-1

Do not use

  • if you ever have had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Naproxen Sodium 220 mg



(Naproxen 200 mg) (NSAID)*



*nonsteroidal anti-inflammatory drug

Section 60561-8

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
Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to

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

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

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

Adults: (12 years of age and older)

  • take 1 tablet every 8 to 12 hours while symptoms last.
  • for the first dose you may take 2 tablets within the first hour.
  • do not exceed 2 tablets in any 8 to 12 hour period
  • do not exceed 3 tablets in a 24 hour period

Children under 12 years:ask a doctor

Warnings and Precautions (34071-1)

Warnings

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

Symptoms may include:

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

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:

  • are age 60 or older
  • have stomach ulcers or bleeding problems
  • take a blood thinner (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

  • take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)

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
Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

  • if you ever have had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Naproxen Sodium 220 mg



(Naproxen 200 mg) (NSAID)*



*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)


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Raw Label Data

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