Naproxen Sodium Headache Pain Caplets / Naproxen Sodium Back and Muscle Pain Caplets

Label information

PAIN RELIEVER / FEVER REDUCER (NSAID)

Drug Facts

Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

• 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

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

are age 60 or olderhave had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAID's (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

SPL UNCLASSIFIED SECTION

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, hear failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

OTC- ASK A DOCTOR SECTION

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, kidney disease, asthma, or had a stroke

you are taking a diuretic 

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

OTC- DO NOT USE SECTION

Do not use 

if you have ever had an allergic reaction to any other pain reliever/fever reducer

right before or after heart surgery 

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 

under a doctor's care for any serious condition

taking any other drug 

OTC - WHEN USING SECTION

When using this product

take with food or milk if stomach upset occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - STOP USE SECTION

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 

you have symptoms of heart problems or stroke:

• chest pain

• trouble breathing

• weakness in one part or side of body

• slurred speech

• leg swelling

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 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

• do not take more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose

• each tablet/caplet contains: sodium 20 mg
• store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Headache Container Label:

[Image in the official label — see DailyMed source]

Back and Muscle Pain- Container

[Image in the official label — see DailyMed source]