PAIN AND FEVER RELIEF- naproxen sodium tablet 
Pioneer Life Sciences, LLC

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Active Ingredient

Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

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.

Heart attack and stroke warning: NSAIDs, except aspirin,
increase the risk of heart attack, heart failure and stroke.
These can be fatal. The risk is higher if you use more than
directed or for longer than directed.

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, kidney disease, asthma, or had a stroke
■ you are taking a diuretic
■ you have problems or serious side effects from
taking pain relievers or fever reducers

ASK DOCTOR/PHARMACIST:

■ under a doctor's care for any serious condition
■ taking any other drug

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
■ you have symptoms of heart problems or stroke:
■ chest pain ■ trouble breathing
■ weakness in one part or side of body
■ slurred speech ■ leg swelling
■ 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 of swelling is present in the painful area
■ any new symptoms appear
You may report side effects to FDA at 1-800-FDA-1088

PREGNANCY

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.

DIRECTIONS

Adults and children 12 years and over

■ take 1 tablet every 8 to 12 hours while symptoms last

■ for the 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 hr period

Children under 12 years

■ ask a doctor

OTHER INFORMATION

■ each tablet contains: sodium 20mg
■ store at 20 to 250C (68 to 770F). Avoid high
humidity and excessive heat above 400C (1040F).

INACTIVE INGREDIENTS

Polyvinyl Pyrolidone, Microcrystalline Cellulose, Starch 1500, Sodium Starch Glycolate, Talc, Magnesium Stearate, FD&C Blue #2, Purified Water, Polysorbate 80, Titanium Dioxide, Polyethylene Glycol, Hypromellose

QUESTIONS OR COMMENTS?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Do not Use:

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

When using this product

■ take with food or milk if stomach upset occurs

PRINCIPAL DISPLAY PANEL

Label

PAIN AND FEVER RELIEF 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblue ((Light Blue)) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code ET;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-003-01300 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20761205/19/2021
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 5/2021
Document Id: c29fe377-2308-9b47-e053-2995a90a3846
Set id: c29fec0c-a858-ef95-e053-2995a90a81d8
Version: 1
Effective Time: 20210518
 
Pioneer Life Sciences, LLC