Back And Muscle All Day Pain Relief - Naproxen Sodium Tablets 220 Mg

Back And Muscle All Day Pain Relief - Naproxen Sodium Tablets 220 Mg
SPL v6
SPL
SPL Set ID 81417810-8a34-c859-e053-2a91aa0a6507
Route
ORAL
Published
Effective Date 2021-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Silicon Dioxide Hypromelloses Polyethylene Glycol, Unspecified Povidone Fd&c Blue No. 2 Microcrystalline Cellulose Croscarmellose Magnesium Stearate Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 141 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2019-06-03

Description

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

Purpose

Purposes Pain reliever/ fever reducer


Medication Information

Warnings and Precautions

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, increases 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 pain due to:

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

temporarily reduces fever

Purpose

Purposes

Pain reliever/ fever reducer

Description

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

24 Ct

90 Ct

100 Ct

Section 50565-1
In case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).

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 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 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

  • 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
Section 50570-1

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 53413-1

Questions or comments? call 1-877-290-4008

Section 53414-9

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

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 older:

  • take 1 tablet every 8 to12 hours while symptoms last
  • for first dose you may take 2 tablets with in 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

Active Ingredient

Naproxen Sodium 220 mg

(naproxen 200 mg)(NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information

each tablet contains: sodium 20 mg

store at 20-25ºC (68-77ºF).

avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.


Structured Label Content

24 Ct (24 CT)

90 Ct (90 CT)

100 Ct (100 CT)

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pain due to:

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

temporarily reduces fever

Warnings and Precautions (34071-1)

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, increases 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 50565-1 (50565-1)
In case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).

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 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 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

  • 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
Section 50570-1 (50570-1)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 53413-1 (53413-1)

Questions or comments? call 1-877-290-4008

Section 53414-9 (53414-9)

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

Purpose (PURPOSE)

Purposes

Pain reliever/ fever reducer

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 older:

  • take 1 tablet every 8 to12 hours while symptoms last
  • for first dose you may take 2 tablets with in 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

Active Ingredient (ACTIVE INGREDIENT)

Naproxen Sodium 220 mg

(naproxen 200 mg)(NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

each tablet contains: sodium 20 mg

store at 20-25ºC (68-77ºF).

avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.


Advanced Ingredient Data


Raw Label Data

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