SPL v1
SPL
SPL Set ID c29fec0c-a858-ef95-e053-2995a90a81d8
Route
ORAL
Published
Effective Date 2021-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ET;9 Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2021-05-19

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 ■ muscular aches

■ backache ■ menstrual cramps

■ headache ■ toothache

■ the common cold

■ temporarily reduces fever

Pregnancy

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.

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

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

Ask Doctor:

■ 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

Do Not Use:

■ if you have ever had an allergic reaction to

any other pain reliever/fever reducer

■ right before or after heart surgery

Active Ingredient

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information

■ each tablet contains: sodium 20mg

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

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

Inactive Ingredients

Polyvinyl Pyrolidone, Microcrystalline Cellulose, Starch 1500, Sodium Starch Glycolate, Talc, Magnesium Stearate, FD&C Blue #2, Purified Water, Polysorbate 80, Titanium Dioxide, Polyethylene Glycol, Hypromellose

Ask Doctor/pharmacist:

■ under a doctor's care for any serious condition

■ taking any other drug

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Principal Display Panel

When Using This Product

■ take with food or milk if stomach upset occurs

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 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.


Structured Label Content

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

Purpose

Pain reliever/Fever reducer

Pregnancy (PREGNANCY)

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.

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)

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

Ask Doctor:

■ 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

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

Active Ingredient

Naproxen sodium 220mg

(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

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).

Inactive Ingredients (INACTIVE INGREDIENTS)

Polyvinyl Pyrolidone, Microcrystalline Cellulose, Starch 1500, Sodium Starch Glycolate, Talc, Magnesium Stearate, FD&C Blue #2, Purified Water, Polysorbate 80, Titanium Dioxide, Polyethylene Glycol, Hypromellose

Ask Doctor/pharmacist: (ASK DOCTOR/PHARMACIST:)

■ under a doctor's care for any serious condition

■ taking any other drug

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

■ take with food or milk if stomach upset occurs

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

■ 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.


Advanced Ingredient Data


Raw Label Data

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