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Naproxen All day relief for pain

Medically reviewed on Dec 25, 2017

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Allegiant Health
NDC Code: 69168-361

Drug Facts

Active ingredient

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

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever

Warnings

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

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

■ 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 doctors care for any serious condition taking any other drug

When using this product

take with food or milk if stomach upset occursthe 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 immediately

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 8-12 hour period do not exceed 3 tablets in a 24-hour period Children under 12 years: ask a doctor

Other Information

each tablet contains: sodium 20mg store at 20-25 °C (68-77° F).■ avoid high humidity and excessive heat above 40 °C (104° F).Do not use if tamper evident seal under bottle cap is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Package/Label Principal Display Panel
NAPROXEN  ALL DAY RELIEF FOR PAIN
naproxen sodium 220 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-361
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code141
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-361-5050 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054512/23/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-361), MANUFACTURE(69168-361), LABEL(69168-361), PACK(69168-361), RELABEL(69168-361), REPACK(69168-361)

 
Allegiant Health

Further information

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

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