NAPROXEN SODIUM- naproxen sodium capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Naproxen Sodium (UNII: 9TN87S3A3C) (Naproxen - UNII:57Y76R9ATQ)
Available from:
WALGREEN COMPANY
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold - minor pain of arthritis - muscular aches - backache - menstrual cramps - headache - toothache - the common cold - temporarily reduces fever
Authorization status:
New Drug Application
Authorization number:
0363-0177-11, 0363-0177-15, 0363-0177-22, 0363-0177-25, 0363-0177-78, 0363-0177-99

NAPROXEN SODIUM- naproxen sodium capsule, liquid filled

WALGREEN COMPANY

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Drug Facts

Active ingredient (in each capsule)

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

Purposes

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

nonsteroidal anti-inflammatory drug

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

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 you are

under a doctor's care for any serious condition

taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin

taking any other drug

When using this product

take with food or milk if stomach upset occurs

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

redness or swelling is present in the painful area

any new symptoms appear

you have difficulty swallowing

it feels like the capsule is stuck in your throat

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

do not take more than directed

the smallest effective dose should be used

drink a full glass of water with each dose

if taken with food, this product may take longer to work

adults and children

12 years and older:

take 1 capsule every 8 to 12 hours while

symptoms last

for the first dose you may take 2 capsules

within the first hour

do not exceed 2 capsules in any 8- to 12-

hour period

do not exceed 3 capsules in a 24-hour

period

children under 12

years:

ask a doctor

Other information

each capsule contains: sodium 20 mg

store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)

read all directions and warnings before use. Keep carton.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol,

povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS TORN OR MISSING

Walgreens Pharmacist Recommended Walgreens Pharmacist Survey

This product is not manufactured or distributed by Bayer HealthCare, LLC, distributor of ALEVE

Liquid Gels.

DISTRIBUTED BY:

WALGREEN CO.,

200 WILMOT RD.,

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2019 Walgreen Co.

ITEM 295751 W00000-0000-0

R0519

ORG0719-F

L0000210

PRINCIPAL DISPLAY PANEL - 220 mg Capsule Bottle Carton

††

®

††

Compare to ALEVE Liquid Gels active ingredient

NDC 0363-0177-11

Naproxen Sodium

CAPSULES, 220 mg (NSAID) /

PAIN RELIEVER / FEVER REDUCER

12 HOUR LIQUID GELS

20 LIQUID-FILLED CAPSULES**

(**LIQUID GELS)

®

††

NAPROXEN SODIUM

naproxen sodium capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 177

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Na pro xen So dium (UNII: 9 TN8 7S3A3C) (Napro xen - UNII:57Y76 R9 ATQ)

Napro xen So dium

220 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

LACTIC ACID (UNII: 33X0 4XA5AT)

MANNITO L (UNII: 3OWL53L36 A)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

BLUE (Blue with white text)

S core

no sco re

S hap e

CAPSULE

S iz e

25mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 36 3-0 177-11 1 in 1 CARTON

0 8 /0 2/20 19

1

20 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:0 36 3-0 177-

1 in 1 CARTON

0 8 /0 2/20 19

2

40 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:0 36 3-0 177-

1 in 1 CARTON

0 8 /0 2/20 19

3

8 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

4

NDC:0 36 3-0 177-

1 in 1 CARTON

0 8 /0 2/20 19

4

120 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

5

NDC:0 36 3-0 177-

18 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 2/20 19

6

NDC:0 36 3-0 177-

8 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 2/20 19

WALGREEN COMPANY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 20

0 8 /0 2/20 19

Labeler -

WALGREEN COMPANY (008965063)

Registrant -

Bionpharma Inc. (079637826)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Patheo n So ftgels Inc.

0 0 219 38 29

ma nufa c ture (0 36 3-0 177)

Revised: 8/2019

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