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All Day Relief by Preferred Pharmaceuticals Inc.

Medically reviewed on December 12, 2017

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-9971

NAPROXEN SODIUM- naproxen sodium tablet, coated
Marksans Pharma Limited

Active ingredient(s)

Naproxen Sodium Tablets, USP
220 mg (NSAID)*
 *nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever/ fever reducer

Use(s)

 temporarily relieves minor aches and pain due to:

backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
temporarily reduces fever

Warnings

Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

asthma (wheezing)
blisters
facial swelling
hives
rash
shock
skin reddening

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 bad stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drug 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

 

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 doctor if

 

 

you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have a stomach pain that dose 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 sluck in your throat
redness or swelling is present in the painful area
any new symptoms appear

Pregnancy/Breastfeeding

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of the 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 accidental overdose, get medical help or contact a poison control center right away.

Directions

 

do not more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directred by a doctor (see Warnings)
drink a full glass of water with each dose

 Adults and children 12 years and older:
 

 

take 1 tablet every 8 to12 hours while symptoms last
for 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 a 24 hours period

 

 children under 12 years:

 

ask a doctor

Storage
Store at 20-25oC (68-77oF). Avoid high humidity and excessive heat above 400C (1040F)

Other information
each tablet contain: sodium 20 mg
Questions or comments? 1-800-645-2158

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

Distributed by

Rugby Laboratories
Livonia, MI 48150  USA

Principal Display Panel

Container label caplets (capsule shaped tablets)


 

ALL DAY RELIEF 
naproxen sodium tablet, coated tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9971(NDC:0536-1023)
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 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL 1000 
POVIDONE K12 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code141
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-9971-220 TABLET in 1 BOTTLE
2NDC:68788-9971-330 TABLET in 1 BOTTLE
3NDC:68788-9971-440 TABLET in 1 BOTTLE
4NDC:68788-9971-660 TABLET in 1 BOTTLE
5NDC:68788-9971-990 TABLET in 1 BOTTLE
6NDC:68788-9971-1100 TABLET in 1 BOTTLE
7NDC:68788-9971-8120 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054505/06/2015
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-9971)

 
Preferred Pharmaceuticals 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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