NAPROXEN SODIUM tablet, film coated

Naproxen Sodium by

Drug Labeling and Warnings

Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each tablet/caplet)

Naproxen sodium 220 mg (Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USE(S)

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.

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, 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 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

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 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 or swelling is present in the painful area
any new symptoms appear

PREGNANCY/BREASTFEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20
weeks or later in 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

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
  • 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-hour period
• Children under 12 years:
  • ask a doctor

OTHER INFORMATION

  each tablet contains: sodium 20 mg
 store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F)

INACTIVE INGREDIENT

Inactive Ingredients FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide



Questions or Comments?

1-844-384-3723 Mon - Fri 9:00 AM to 4:30 PM EST

Do not use if carton is open or of foil seal on bottle opening is missing or broken.



Manufactured for:
Safrel Pharmaceuticals

Bridgewater, NJ 08807

www.safrel.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 
naproxen sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	OVAL (Caplet -Shaped)	Size	12mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-109-04	400 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091353	09/30/2021

Labeler - Safrel Pharmaceuticals, LLC. (080566287)