Naproxen Sodium Tablets, Usp 220 Mg (nsaid)

Naproxen Sodium Tablets, Usp 220 Mg (nsaid)
SPL v3
SPL
SPL Set ID 9e9dc1fb-aa0f-4948-b4aa-75a94f9f9d57
Route
ORAL
Published
Effective Date 2021-02-09
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Fd&c Blue No. 2 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Povidone, Unspecified Sodium Starch Glycolate Type A Potato Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ET10 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2019-12-11

Description

(in each tablet) Naproxen sodium 220mg (naproxen 200mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

(in each tablet) Naproxen sodium 220mg (naproxen 200mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Use(s)

■ 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

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 had stomach ulcers or bleeding problems

■ take a blood thinning (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: NSAIDs, 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.

Directions

do not take more than directed

the smallest effective dose should be used

■ drink a full glass of water with each dose



Adults and

children 12 years

and over

■ 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-hr period

Children under 12 years

■ ask a doctor





Do Not Use

■ if you have ever had an allergic reaction to

    any other pain reliever/fever reducer

■ right before or after heart surgery

Naproxen Sodium
Other Information


■ each tablet contains: sodium 20mg

■ store at 20 to 250C (68 to 770F). Avoid high

humidity and excessive heat above 400C (1040F).



Active Ingredient(s)

(in each tablet)

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, starch, talc, titanium dioxide

Questions Or Comments

888-588-1418 (MON - FRI 9 AM to 5 PM EST)



Distributed By: Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA





Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

When Using This Product

■ take with food or milk if stomach upset occurs

Ask A Doctor Before Use If

■ the 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

Stop Use and Ask 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 more than 10 days

■ fever gets worse or lasts more than 3 days

■ you have difficulty swallowing

■ it feels like the pill is stuck in your throat

■ redness of swelling is present in the painful area

■ any new symptoms appear

You may report side effects to FDA at 1-800-FDA-1088

Keep Out of Reach of Children

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

Ask A Doctor Or Pharmacist Before Use If

■ under a doctor's care for any serious condition

■ taking any other drug


Structured Label Content

Use(s) (USE(S))

■ 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

Purpose (PURPOSE)

Pain reliever/Fever reducer

Warnings (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 had stomach ulcers or bleeding problems

■ take a blood thinning (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: NSAIDs, 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.

Directions (DIRECTIONS)

do not take more than directed

the smallest effective dose should be used

■ drink a full glass of water with each dose



Adults and

children 12 years

and over

■ 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-hr period

Children under 12 years

■ ask a doctor





Do Not Use (DO NOT USE)

■ if you have ever had an allergic reaction to

    any other pain reliever/fever reducer

■ right before or after heart surgery

Naproxen Sodium (Naproxen sodium)
Other Information (OTHER INFORMATION)


■ each tablet contains: sodium 20mg

■ store at 20 to 250C (68 to 770F). Avoid high

humidity and excessive heat above 400C (1040F).



Active Ingredient(s) (ACTIVE INGREDIENT(S))

(in each tablet)

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (INACTIVE INGREDIENTS)

FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, starch, talc, titanium dioxide

Questions Or Comments (QUESTIONS OR COMMENTS)

888-588-1418 (MON - FRI 9 AM to 5 PM EST)



Distributed By: Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA





Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

When Using This Product (WHEN USING THIS PRODUCT)

■ take with food or milk if stomach upset occurs

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

■ the 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

Stop Use and Ask Doctor If (STOP USE AND ASK 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 more than 10 days

■ fever gets worse or lasts more than 3 days

■ you have difficulty swallowing

■ it feels like the pill is stuck in your throat

■ redness of swelling is present in the painful area

■ any new symptoms appear

You may report side effects to FDA at 1-800-FDA-1088

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

■ under a doctor's care for any serious condition

■ taking any other drug


Advanced Ingredient Data


Raw Label Data

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