Topcare Naproxen Sodium

Topco Associates LLC

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

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each capsule)
• Purpose
• Topcare Naproxen Sodium Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Topcare Naproxen Sodium Other information
• Inactive ingredients
• Questions or comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Topcare Naproxen Sodium 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

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

Do not use

• •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

• •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

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

When using this product

• •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

• •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,

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 right away. (1-800-222-1222)

Directions

• •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

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 periodask a doctor

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adults and children 12 years and older:
children under 12 years:

Topcare Naproxen Sodium Other information

• •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

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

Questions or comments?

1-888-423-0139

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)

Topcare Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED Product Information Product Type Human otc drug label Item Code (Source) NDC:36800-742 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength naproxen sodium NAPROXEN 220 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 GELATIN GLYCERIN LACTIC ACID mannitol POLYETHYLENE GLYCOLS POVIDONES propylene glycol water SORBITAN sorbitol Product Characteristics Color Size Imprint Code Shape BLUE (Clear) 20 mm 742 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 20 in 1 BOTTLE 2 40 in 1 BOTTLE 3 80 in 1 BOTTLE 4 100 in 1 BOTTLE 5 160 in 1 BOTTLE 6 NDC:36800-742-06 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021920 2010-11-23