naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet

Generic Name: NAPROXEN SODIUM
Brand Name: up and up naproxen sodium
  • Substance Name(s):
  • NAPROXEN SODIUM

WARNINGS

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 •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, 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)

INDICATIONS AND USAGE

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

INACTIVE INGREDIENTS

Inactive ingredients FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

PURPOSE

Purposes Pain reliever/fever reducer

KEEP OUT OF REACH OF CHILDREN

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)

ASK DOCTOR

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

DOSAGE AND ADMINISTRATION

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 caplet every 8 to 12 hours while symptoms last •for the first dose you may take 2 caplets within the first hour •do not exceed 2 caplets in any 8- to 12-hour period •do not exceed 3 caplets in a 24-hour period Children under 12 years •ask a doctor

PREGNANCY AND 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.

DO NOT USE

Do not use •if you have ever had an allergic reaction to any other pain reliever/fever reducer •right before or after heart surgery

STOP USE

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

ACTIVE INGREDIENTS

Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

ASK DOCTOR OR PHARMACIST

Ask a doctor or pharmacist before use if you are •under a doctor’s care for any serious condition •taking any other drug