NAPROXEN SODIUM- naproxen sodium tablet, film coated

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

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Active ingredient:
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer
Product summary:
Product: 71335-1061 NDC: 71335-1061-1 20 TABLET, FILM COATED in a BOTTLE NDC: 71335-1061-2 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-1061-3 40 TABLET, FILM COATED in a BOTTLE NDC: 71335-1061-4 50 TABLET, FILM COATED in a BOTTLE NDC: 71335-1061-5 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-1061-6 14 TABLET, FILM COATED in a BOTTLE NDC: 71335-1061-7 100 TABLET, FILM COATED in a BOTTLE NDC: 71335-1061-8 90 TABLET, FILM COATED in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
71335-1061-1, 71335-1061-2, 71335-1061-3, 71335-1061-4, 71335-1061-5, 71335-1061-6, 71335-1061-7, 71335-1061-8

NAPROXEN SODIUM- naproxen sodium tablet, film coated

Bryant Ranch Prepack

----------

Perrigo Naproxen Sodium Tablets 220 mg Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos es

Pain reliever/fever reducer

Us es

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to

aspirin. Symptoms may include:

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:

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

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid 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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

if you have ever had an allergic reaction to any other pain reliever/fever reducer

right before or after heart surgery

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

under a doctor’s care for any serious condition

taking any other drug

take with food or milk if stomach upset occurs

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

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 (1-800-222-1222).

Directions

Adults and

children 12 years

and older

Children under 12

years

Other information

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose,

polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

HOW SUPPLIED

Product: 71335-1061

NDC: 71335-1061-1 20 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1061-2 30 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1061-3 40 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1061-4 50 TABLET, FILM COATED in a BOTTLE

redness or swelling is present in the painful area

any new symptoms appear

do not take more than directed

the smallest effective dose should be used

drink a full glass of water with each dose

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

ask a doctor

each tablet contains: sodium 21 mg

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

NDC: 71335-1061-5 60 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1061-6 14 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1061-7 100 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1061-8 90 TABLET, FILM COATED in a BOTTLE

Naproxen Sodium 220mg Tablet

NAPROXEN SODIUM

naproxen sodium tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71335-10 6 1(NDC:458 0 2-49 0 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NAPRO XEN SO DIUM (UNII: 9 TN8 7S3A3C) (NAPROXEN - UNII:57Y76 R9 ATQ)

NAPROXEN SODIUM

220 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

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

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Bryant Ranch Prepack

Product Characteristics

Color

BLUE (Light Blue)

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

L49 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71335-10 6 1-1

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

2

NDC:71335-10 6 1-2

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

3

NDC:71335-10 6 1-3

40 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

4

NDC:71335-10 6 1-4

50 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

5

NDC:71335-10 6 1-5

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

6

NDC:71335-10 6 1-6

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

7

NDC:71335-10 6 1-7

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

8

NDC:71335-10 6 1-8

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 1/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 746 6 1

0 4/11/20 14

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(71335-10 6 1) , RELABEL(71335-10 6 1)

Revised: 2/2019

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