All Day Relief

Rugby Laboratories

NAPROXEN SODIUM- naproxen sodium tablet, coatedMarksans Pharma Limited

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient(s)
• Purpose
• Use(s)
• Warnings
• Do not use
• Ask a doctor before use if
• Ask a doctor or pharmacist before use if
• When using this product
• Stop use and ask doctor if
• Pregnancy/Breastfeeding
• Keep out of reach of children
• Directions
• Storage
• All Day Relief Other information
• Inactive ingredients
• Distributed by
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient(s)

Naproxen Sodium Tablets, USP
220 mg (NSAID)*
 *nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever/ fever reducer

Use(s)

 temporarily relieves minor aches and pain due to:

• backache
• headache
• menstrual cramps
• minor pain of arthritis
• muscular aches
• the common cold
• toothache
• temporarily reduces fever

Warnings

Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• asthma (wheezing)
• blisters
• facial swelling
• hives
• rash
• shock
• skin reddening

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 bad stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drug 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

• 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 doctor if

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have a stomach pain that dose 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 sluck in your throat
• redness or swelling is present in the painful area
• any new symptoms appear

Pregnancy/Breastfeeding

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of the 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 accidental overdose, get medical help or contact a poison control center right away.

Directions

• do not more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directred by a doctor (see Warnings)
• drink a full glass of water with each dose

Storage

• Store at 20-25^oC (68-77^oF). Avoid high humidity and excessive heat above 40⁰C (104⁰F)

All Day Relief Other information

• each tablet contain: sodium 20 mg
• Questions or comments? 1-800-645-2158

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

Distributed by

Rugby Laboratories
Livonia, MI 48150  USA

Principal Display Panel

Container label caplets (capsule shaped tablets)

Container label  tablets (round shaped)