Topco Associates LLC. Naproxen Sodium Capsules, 220 mg (NSAID) Drug Facts

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (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
• muscular aches
• backache
• menstrual cramps
• headache
• toothache
• the common cold
• temporarily reduces fever

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE 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

OTC - ASK DOCTOR SECTION

• 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, 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

OTC - ASK DOCTOR/PHARMACIST SECTION

• under a doctor’s care for any serious condition
• taking any other drug

When using this product

OTC - WHEN USING SECTION

• take with food or milk if stomach upset occurs
• the 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

OTC - STOP USE 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
• redness or swelling is present in the painful area
• any new symptoms appear
• you have difficulty swallowing
• it feels like the capsule is stuck in your throat

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING 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 right away. (1-800-222-1222)

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
• if taken with food, this product may take longer to work

adults and children 12 years and older:	take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period
children under 12 years:	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each capsule contains: sodium 20 mg
• store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)
• do not use if printed foil under cap is broken or missing
• read all directions and warnings before use. Keep carton.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Naproxen Sodium CAPSULES, 220 mg (NSAID)

Pain Reliever / Fever Reducer

actual size

COMPARE TO the active ingredient of ALEVE® LIQUID GELS

Strength to last 12 hours

†(Liquid Filled Capsules)

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

• Topcare Naproxen Sodium
• Naproxen sodium
• NAPROXEN
• FD&C BLUE NO. 1
• GELATIN
• GLYCERIN
• LACTIC ACID
• MANNITOL
• POLYETHYLENE GLYCOL
• POVIDONE
• PROPYLENE GLYCOL
• WATER
• SORBITAN
• SORBITOL

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

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Inactive ingredient matches#

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Orange Book patents#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

Observed Orange Book patent history#

Patent history page 1 of 9 · 329 observed states.

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Reported adverse events (FAERS/openFDA)#

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