Naproxen Sodium- Naproxen Sodium Tablet,coated

SPL v8

SPL

SPL Set ID 48cb1363-ff12-40ee-a87a-2252dfbf8ff7

Route

ORAL

Published

Effective Date 2023-06-14

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Naproxen (220 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 2 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Povidone Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 141 Shape: oval Shape: round Color: blue Size: 12 mm Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2011-05-28

Description

For Tablets: Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug For Caplets: Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Medication Information

Purpose

Pain reliever/ fever reducer

Description

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.

Directions

For Tablets:

• 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

For Caplets:

• 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 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets 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

Other Information

For Tablets:

• each tablet contains: sodium 20 mg

• store at 20-25ºC (68-77ºF).

• avoid high humidity and excessive heat above 40°C (104°F).

For Caplets:

• each caplet contains: sodium 20 mg

• store at 20-25ºC (68-77ºF).

• avoid high humidity and excessive heat above 40°C (104°F).

Active Ingredient(s)

For Tablets:

Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

For Caplets:

Active ingredient (in each caplet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

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 toll free 1-877-376-4271

Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue, Farmingdale,

NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, Goa - 403722, India.

Mfg. Lic. No.: GO/DRUGS/515

Principal Display Panel

NDC 25000-141-43

Naproxen Sodium Tablets, USP 220 mg

10’s count bottle label

NDC 25000-141-43

Naproxen Sodium Tablets, USP 220 mg

10’s count carton label

NDC 25000-141-02

Naproxen Sodium Tablets, USP 220 mg

24’s count bottle label

NDC 25000-141-02

Naproxen Sodium Tablets, USP 220 mg

24’s count carton label

NDC 25000-141-14

Naproxen Sodium Tablets, USP 220 mg

1000’s count bottle label

NDC 25000-144-14

Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)

1000’s count bottle label

NDC 25000-144-43

Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)

10’s count bottle label

NDC 25000-144-43

Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)

10’s count carton label

NDC 25000-144-02

Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)

24’s count bottle label

NDC 25000-144-02

Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)

24’s count carton label

When Using This Product

• take with food or milk if stomach upset occurs

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

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

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)

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.

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

Structured Label Content

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

Purpose

Pain reliever/ fever reducer

Warnings

Directions

For Tablets:

• 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

For Caplets:

• 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 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets 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

Other Information (Other information)

For Tablets:

• each tablet contains: sodium 20 mg

• store at 20-25ºC (68-77ºF).

• avoid high humidity and excessive heat above 40°C (104°F).

For Caplets:

• each caplet contains: sodium 20 mg

• store at 20-25ºC (68-77ºF).

• avoid high humidity and excessive heat above 40°C (104°F).

Active Ingredient(s) (Active ingredient(s))

For Tablets:

Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

For Caplets:

Active ingredient (in each caplet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

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?)