Naproxen

Label at a glance#

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Do not use

SPL UNCLASSIFIED SECTION

if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or
after heart surgery

Ask a doctor before use if

SPL UNCLASSIFIED SECTION

■ 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

Ask a doctor or pharmacist before use if you are

SPL UNCLASSIFIED SECTION

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

When using this product

SPL UNCLASSIFIED SECTION

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

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

Other Information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Naproxen All day relief for pain
• Naproxen Sodium 220 mg
• NAPROXEN SODIUM
• NAPROXEN
• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• FD&C BLUE NO. 2
• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYETHYLENE GLYCOLS
• POVIDONES
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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Source XML

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Inactive ingredient links page 1 of 5 · 246 matching rows.

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Observed Orange Book product history#

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