ALL DAY RELIEF- naproxen sodium tablet, coated tablet 
REMEDYREPACK INC.

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NAPROXEN SODIUM- naproxen sodium tablet, coatedMarksans Pharma Limited

OTC - ACTIVE INGREDIENT

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

 

OTC - PURPOSE

Pain reliever/ fever reducer

 

INDICATIONS & USAGE

 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.

 

OTC - DO NOT USE

 

  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after heart surgery

 

OTC - ASK DOCTOR

 

  • 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

 

OTC - ASK DOCTOR/PHARMACIST

 

  • under a doctor’s care for any serious condition
  • taking any other drug

 

OTC - WHEN USING

 

  • 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

 

OTC - STOP USE

 

 

  • 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

 

OTC - PREGNANCY OR BREAST FEEDING

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.

 

OTC - KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, get medical help or contact a poison control center right away.

 

DOSAGE & ADMINISTRATION

 

  • 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 AND HANDLING

  • Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)

 

SPL UNCLASSIFIED

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

 

INACTIVE INGREDIENT

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

 

SPL UNCLASSIFIED

Rugby Laboratories
Livonia, MI 48150  USA

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: All Day Relief


GENERIC: Naproxen Sodium Tablet, coated


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 61786-171-02


ACTIVE INGREDIENT(S):

  • NAPROXEN SODIUM 220mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POLYETHYLENE GLYCOL 1000
  • MAGNESIUM STEARATE
  • POVIDONE K12
  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • FD&C BLUE NO. 2
  • HYPROMELLOSES
  • TITANIUM DIOXIDE


COLOR: blue


SHAPE: ROUND


SCORE: No score


SIZE: 10 mm


IMPRINT: 141


PACKAGING: 30 in 1 BLISTER PACK




MM1

MM2

ALL DAY RELIEF 
naproxen sodium tablet, coated tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-171(NDC:0536-1023)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K12 (UNII: 333AG72FWJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeROUND (TABLET) Size10mm
FlavorImprint Code 141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-171-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product02/02/201503/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054502/02/201503/10/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
 
REMEDYREPACK INC.