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Flanax Pain and Fever Reliever

Medically reviewed on September 21, 2018

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-154

Flanax Pain & Fever Reliever

Drug Facts

Active ingredient (in each tablet)

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

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to: 
• minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • also temporarily reduces fever.

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
• hives • asthma (wheezing) • skin reddening • facial swelling • shock • 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 non-prescription 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 reliever 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 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:
• you 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.

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 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)

Inactive ingredients

Croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Questions or comments?

Please Call 1-888-535-2629 M-F 9AM-5PM CST.

Package Labeling:

FLANAX PAIN AND FEVER RELIEVER 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-154(NDC:27854-103)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
POLYETHYLENE GLYCOL, UNSPECIFIED 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScore2 pieces
ShapeROUNDSize10mm
FlavorHONEYImprint CodeI3
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-154-011 POUCH in 1 CARTON
12 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909609/20/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

 
Navajo Manufacturing Company Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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