NAPROXEN SODIUM- naproxen sodium tablet 
DirectRx

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Naproxen Sodium

Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/ fever reducer

temporarily relieves minor aches and pain due to:

backache
muscular aches
minor pain of arthritis
menstrual cramps
headache
toothache
the common cold

temporarily reduces fever

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.

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

if you have ever had an allergic reaction to any other pain reliever / fever reducer
right before or after heart surgery

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

under a doctor's care for any serious condition
taking any other drug

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

you have symptoms of heart problems or stroke

 leg swelling  chest pain
 slurred speech  trouble breathing
 weakness in one part or side of body

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 (1-800-222-1222) right away.

Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, silicon dioxide, talc, titanium dioxide

Call 1-800-540-3765

hi

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-272(NDC:57896-954)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;417
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72189-272-4040 in 1 BOTTLE; Type 0: Not a Combination Product12/17/202108/31/2023
2NDC:72189-272-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/17/202108/31/2023
3NDC:72189-272-1414 in 1 BOTTLE; Type 0: Not a Combination Product12/17/202108/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20487212/17/202108/31/2023
Labeler - DirectRx (079254320)
Registrant - DirectRx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRx079254320repack(72189-272)

Revised: 7/2023
 
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