NAPROXEN SODIUM <br/>TABLETS USP, 220 mg
Naproxen Sodium Headache Pain Caplets Naproxen Sodium Naproxen Sodium Naproxen FD&C BLUE NO. 2 hypromelloses magnesium stearate cellulose, microcrystalline POLYETHYLENE GLYCOL, UNSPECIFIED povidone talc titanium dioxide POLYSORBATE 80 R;273 Naproxen Sodium Back and Muscle Pain Caplets Naproxen Sodium Naproxen Sodium Naproxen FD&C BLUE NO. 2 hypromelloses magnesium stearate cellulose, microcrystalline POLYETHYLENE GLYCOL, UNSPECIFIED povidone talc titanium dioxide POLYSORBATE 80 R;273
Back and Muscle Pain Headache Pain Container
<text> <paragraph> <content styleCode="bold">PAIN RELIEVER / FEVER REDUCER (NSAID)</content> </paragraph> <paragraph> <content styleCode="bold">Drug Facts</content> </paragraph> </text> <effectiveTime value="20210604"/> </section> </component> <component> <section ID="_fd336464-8171-f532-61df-33b1188d6e62"> <id root="08402265-c185-bb8d-a535-fcc6f5cb093d"/> <code code="55106-9" displayName="OTC - ACTIVE INGREDIENT SECTION" codeSystem="2.16.840.1.113883.6.1"/> <title> <content styleCode="italics">Active ingredient (in each tablet/caplet)</content> Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)nonsteroidal anti-inflammatory drug
<content styleCode="italics">Purposes</content> Pain reliever/fever reducer
<content styleCode="italics">Uses</content> 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
<content styleCode="italics">Warnings</content>
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 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.
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).
<content styleCode="italics">Directions</content> 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/caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets/caplets within the first hour do not exceed 2 tablets/caplets in any 8 to 12 hour period do not exceed 3 tablets/caplets in a 24-hour period
Children under 12 years ask a doctor
<content styleCode="italics">Other information</content> 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).
<content styleCode="italics">Inactive ingredients</content> FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
<content styleCode="italics"> <content styleCode="bold">Questions or comments?</content> </content> call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
<text> <paragraph> <sup/>Distributed by:</paragraph> <paragraph> <content styleCode="bold">Dr. Reddy’s Laboratories, Inc.</content> </paragraph> <paragraph>Princeton, NJ 08540 </paragraph> </text> <effectiveTime value="20210604"/> </section> </component> <component> <section ID="_78c07eab-1ce8-04f6-7d8e-117f544a20bb"> <id root="0e1c710b-a422-ef6b-eaa4-0cc1cb581edc"/> <code code="51945-4" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL" codeSystem="2.16.840.1.113883.6.1"/> <title>Headache Pain Headache Pain - Container
Back and Muscle Pain Back and Muscle Pain- Container