FDA Label for Calmadol Pain Reliever

Active Ingredients (In Each Tablet)

Naproxen sodium 220 mg

(naproxen 200 mg)(NSAID)*

Purpose

Pain reliever/

fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ headache ■ common cold ■ muscular aches

■backache ■ toothache ■ menstrual cramps

■minor pain of arthritis

■temporarily reduces fever

Otc - Pregnancy Or Breast Feeding

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.

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 ■ blisters ■ rash

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 problems or serious side effects from taking pain relievers or fever reducers

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

■ 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

■ 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

Directions

■ 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 to 12-hour period

■ do not exceed 3 tablets in a 24-hour period

■ Children under 12 years: Ask a doctor

Other Information:

Each tablet contains sodium 20 mg. Store at 20-25 C (68-77°F) Avoid high humidity and excessive heat above 40°C (104°F). Keep Carton.

Questions

If you have questions of a medical nature, please conact your pharmacist, doctor or health care professional.

Other

Distributed by: Grandall Distributing Co., Inc. Glendale, CA 91204-2707

Inactive Ingredients

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

Package Labeling

CALMADOL

PAIN RELIEVER

FEVER REDUCER

Naproxen Sodium Tablets

220 mg (NSAID)

24 TABLETS

CalmadolTabLabel.jpg - CalmadolTabLabel