ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated 
CVS Pharmacy

----------

CVS Pharmacy, Inc. All Day Pain Relief 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, 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

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. (1-800-222-1222)

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 21 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 no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Aleve®

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, 220 mg

Pain reliever / Fever reducer (NSAID)

Strength to last 12 hours

50 CAPLETS

CAPSULE-SHAPED TABLETS

Actual size

CVS Pharmacy, Inc. All Day Pain Relief
CVS Pharmacy, Inc. All Day Pain Relief
ALL DAY PAIN RELIEF 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-368
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeCAPSULE (oval) Size12mm
FlavorImprint Code L368
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-368-621 in 1 CARTON
124 in 1 BOTTLE
2NDC:59779-368-711 in 1 CARTON
250 in 1 BOTTLE
3NDC:59779-368-821 in 1 CARTON
3200 in 1 BOTTLE
4NDC:59779-368-90500 in 1 BOTTLE
5NDC:59779-368-721 in 1 CARTON
560 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07466101/23/1997
Labeler - CVS Pharmacy (062312574)

Revised: 12/2013
Document Id: 53d088d5-7c51-470f-b943-34ba3d80e7fc
Set id: 35e61597-17c5-4460-b02d-2928c401a154
Version: 3
Effective Time: 20131203
 
CVS Pharmacy