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All Day Relief by Rugby Laboratories

Medically reviewed on Feb 26, 2018

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Rugby Laboratories
NDC Code: 0536-1023

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)



Container label  tablets (round shaped)


 

ALL DAY RELIEF 
naproxen sodium tablet, coated tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 1000 
POVIDONE K12 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code141
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1023-061 BOTTLE (1 BOTTLE) in 1 CARTON
150 TABLET (50 TABLET) in 1 BOTTLE
2NDC:0536-1023-011 BOTTLE (1 BOTTLE) in 1 CARTON
2100 TABLET (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054503/10/2014
ALL DAY RELIEF 
naproxen sodium, coated tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1022
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 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 1000 
POVIDONE K12 
TITANIUM DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize12mm
FlavorImprint Code144
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1022-011 BOTTLE (1 BOTTLE) in 1 CARTON
1100 TABLET (100 TABLET) in 1 BOTTLE
2NDC:0536-1022-061 BOTTLE (1 BOTTLE) in 1 CARTON
250 TABLET (50 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054503/10/2014
Labeler - Rugby Laboratories (191427277)

 
Rugby Laboratories

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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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