PAIN ZERO- naproxen sodium tablet 
Provision Medical Products

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Uses:

Temporarily relieves minor aches and pains due to:

backache • headache • menstrual cramps • minor arthritis pains

muscular aches • the common cold • toothache

temporarily reduces fever

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.

Warnings:

Allergy alert:

Naproxen sodium may cause a severe allergic reaction, especially

in people allergic to aspirin. Symptoms may include:

asthma • 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 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 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/serious side effects from taking pain relivers/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 upset stomach

• 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 area

• any new symptoms appear

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 tablet every 8 to 12 hours while

symptoms last

• 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-hour period

Inactive Ingredients:

carnauba wax, croscarmellose sodium,

hydroxypropyl methylcellulose,

microcrystalline cellulose, povidone,FD&C Blue #2

polyethylene glycol,  silicon dioxide, magnesium stearate, titanium dioxide.

ACTIVE INGREDIENT-NAPROXEN SODIUM 220 MG

(NSAID) PAIN RELIEVER/FEVER REDUCER

Pain Zero Box

PAIN ZERO 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2596
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2596-250 in 1 CARTON04/05/2015
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054503/31/201510/02/2017
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Ultraseal Corporation085752004pack(69103-2596)
Establishment
NameAddressID/FEIBusiness Operations
SHASUN PHARMACEUTICALS LIMITED915786829manufacture(69103-2596)

Revised: 11/2017
 
Provision Medical Products