Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1b97ae91-7304-49f3-a5aa-38973bb61c49
Route
ORAL
Published
Effective Date 2014-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 141 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2014-12-23

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Uses

temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever

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 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 8-12 hour period do not exceed 3 tablets in a 24-hour 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

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

Active Ingredient

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information

each tablet contains: sodium 20mg store at 20-25 °C (68-77° F).■ avoid high humidity and excessive heat above 40 °C (104° F). Do not use if tamper evident seal under bottle cap is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

When Using This Product

take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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

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, or kidney disease ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have asthma

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 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

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center immediately

Package/label Principal Display Panel
Ask A Doctor Or Pharmacist Before Use If You Are

under a doctors care for any serious condition taking any other drug


Structured Label Content

Uses

temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever

Purpose

Pain reliever/fever reducer

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 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 8-12 hour period do not exceed 3 tablets in a 24-hour 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

Allergy Alert (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

Active Ingredient (Active ingredient)

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information

each tablet contains: sodium 20mg store at 20-25 °C (68-77° F).■ avoid high humidity and excessive heat above 40 °C (104° F). Do not use if tamper evident seal under bottle cap is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

When Using This Product (When using this product)

take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stomach Bleeding Warning (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

Ask A Doctor Before Use If (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, or kidney disease ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have asthma

Stop Use and Ask A Doctor If (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 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

If Pregnant Or Breast Feeding (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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center immediately

Package/label Principal Display Panel (Package/Label Principal Display Panel)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

under a doctors care for any serious condition taking any other drug


Advanced Ingredient Data


Raw Label Data

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