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rexall all day pain relief by Dolgencorp Inc

Dosage form: tablet, film coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Dolgencorp Inc
NDC Code: 55910-371

Dolgencorp, LLC 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

Principal Display Panel

All Day Pain Relief

STRENGTH TO LAST 12 HOURS

Naproxen Sodium Tablets USP 220mg

Pain Reliever/Fever Reducer (NSAID)

24 Caplets**

**Capsule-shaped tablets

actual size

REXALL ALL DAY PAIN RELIEF 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-371
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 CodeL368
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-371-621 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07466109/28/2012
Labeler - Dolgencorp Inc (068331990)

Revised: 12/2013
 
Dolgencorp Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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