Gc 951-954l

Gc 951-954l
SPL v3
SPL
SPL Set ID f1ed8384-83d6-6f2a-e053-2a95a90ab08f
Route
ORAL
Published
Effective Date 2023-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;417 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2019-01-01

Description

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

Naproxen sodium 220 mg (Naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

temporarily relieves minor aches and pain due to:

  • backache
  • muscular aches
  • minor pain of arthritis
  • menstrual cramps
  • headache
  • toothache
  • the common cold

temporarily reduces fever

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.

Storage

  • Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)
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
  • 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

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
  • each tablet contains: sodium 20 mg

Inactive Ingredients

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl

alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

Call 1-800-540-3765

Principal Display Panel

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 a stomach pain that dose not get better

  • you have symptoms of heart problems or stroke

 leg swelling  chest pain

 slurred speech  trouble breathing

 weakness in one part or side of body

  • 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Naproxen sodium 220 mg

(Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If
  • under a doctor's care for any serious condition
  •   taking any other drug

Structured Label Content

Uses

temporarily relieves minor aches and pain due to:

  • backache
  • muscular aches
  • minor pain of arthritis
  • menstrual cramps
  • headache
  • toothache
  • the common cold

temporarily reduces fever

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.

Purpose

Pain reliever/ fever reducer

Storage

  • Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)
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
  • 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

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)
  • each tablet contains: sodium 20 mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl

alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-540-3765

Principal Display Panel

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs

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, 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 (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 a stomach pain that dose not get better

  • you have symptoms of heart problems or stroke

 leg swelling  chest pain

 slurred speech  trouble breathing

 weakness in one part or side of body

  • 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 (Keep out of reach of children)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Naproxen sodium 220 mg

(Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • under a doctor's care for any serious condition
  •   taking any other drug

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)