Proxen Np 660

Proxen Np 660
SPL v3
SPL
SPL Set ID 09990b2f-202e-b4df-e063-6394a90a055b
Route
ORAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Hypromellose, Unspecified Fd&c Blue No. 2 Aluminum Lake Povidone, Unspecified Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Titanium Dioxide Silicon Dioxide Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: 220 Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2023-11-07

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

■ temporarily relieves minor aches and pains due to:

■ headache ■ backache ■ muscular aches

■ the common cold ■ toothache ■ menstrual cramps

■ minor pain of arthritis ■ temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

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.

Section 55105-1

Active ingredient (in each tablet) Purposes

Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

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 to12 hour period

■ do not exceed 3 tablets in a 24 hour period

Children under 12 years

■ ask a doctor

Do Not Use

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

■ right before or after heart surgery

Allergy Alert:

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives ■ asthma (wheezing) ■ skin reddening

■ facial swelling ■ shock ■ rash ■ blisters

If an allergic reaction occurs, stop use and seek medical help right away.

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)

■ read all product information before using

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions Or Comments?

Call: (619) 600-5632 (Mon-Fri 9AM – 5PM EST) or https://www.opmx.us

When Using This Product

■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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

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 or serious side effects from taking pain relievers or fever reducers

■ you have asthma

Stop Use and Ask A Doctor If

■ side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

■ 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 painful area

■ any new symptoms appear

Principal Display Panel 12 Caplets

NDC 69729-123-12

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

12 Caplets

Principal Display Panel 24 Caplets

NDC 69729-123-24

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

24 Caplets

Principal Display Panel 100 Caplets

NDC 69729-123-50

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

100 Caplets

Ask A Doctor Or Pharmacist Before Use If You Are

■ under a doctor's care for any serious condition

■ taking any other drug


Structured Label Content

Uses

■ temporarily relieves minor aches and pains due to:

■ headache ■ backache ■ muscular aches

■ the common cold ■ toothache ■ menstrual cramps

■ minor pain of arthritis ■ temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Active ingredient (in each tablet) Purposes

Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

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 to12 hour period

■ do not exceed 3 tablets in a 24 hour period

Children under 12 years

■ ask a doctor

Do Not Use (Do not use)

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

■ right before or after heart surgery

Allergy Alert: (Allergy alert:)

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives ■ asthma (wheezing) ■ skin reddening

■ facial swelling ■ shock ■ rash ■ blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information (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)

■ read all product information before using

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call: (619) 600-5632 (Mon-Fri 9AM – 5PM EST) or https://www.opmx.us

When Using This Product (When using this product)

■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stomach Bleeding Warning: (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

Ask A Doctor Before Use If (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 or serious side effects from taking pain relievers or fever reducers

■ you have asthma

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

■ 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 painful area

■ any new symptoms appear

Principal Display Panel 12 Caplets (PRINCIPAL DISPLAY PANEL 12 CAPLETS)

NDC 69729-123-12

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

12 Caplets

Principal Display Panel 24 Caplets (PRINCIPAL DISPLAY PANEL 24 CAPLETS)

NDC 69729-123-24

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

24 Caplets

Principal Display Panel 100 Caplets (PRINCIPAL DISPLAY PANEL 100 CAPLETS)

NDC 69729-123-50

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

100 Caplets

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

■ under a doctor's care for any serious condition

■ taking any other drug


Advanced Ingredient Data


Raw Label Data

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