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Aleve by Navajo Manufacturing Company Inc

Medically reviewed on December 15, 2017

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Navajo Manufacturing Company Inc
NDC Code: 67751-144

Aleve

Drug Facts

Active ingredient (in each caplet)

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

*nonsteroidal anti-inflammatory drug

Purposes

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

  • temporarily reduces fever

Warnings

Allergy alert

Naproxen sodium may cause a severe allergic reaction, especialy in people allergic to asprin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blister

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 chace 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, napoxen, 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.

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

Other Information
  • each caplet 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

FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-395-0689 (Mon - Fri 9AM - 5PM EST) or www.aleve.com

PRINCIPAL DISPLAY PANEL - 12 POUCH DISPENSIT

ALEVE 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-144(NDC:0280-6000)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
TITANIUM DIOXIDE 
POVIDONES 
TALC 
MAGNESIUM STEARATE 
FD&C BLUE NO. 2 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint CodeAleve
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-144-031 POUCH in 1 CARTON
11 TABLET in 1 POUCH
2NDC:67751-144-042 POUCH in 1 CARTON
21 TABLET in 1 POUCH
3NDC:67751-144-0512 POUCH in 1 TRAY
31 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020412/04/2017
Labeler - Navajo Manufacturing Company Inc (091917799)
Establishment
NameAddressID/FEIOperations
Navajo Manufacturing Company Inc136941411relabel(67751-144), repack(67751-144)

 
Navajo Manufacturing Company Inc

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Further information

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

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