608r Walgreen 0363-9608 Naproxen Sodium Caplets All Day Pain Relief

608r Walgreen 0363-9608 Naproxen Sodium Caplets All Day Pain Relief
SPL v9
SPL
SPL Set ID 8771b84f-47bf-116c-e053-2995a90a0aad
Route
ORAL
Published
Effective Date 2022-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 144 Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2019-06-26

Description

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


Medication Information

Warnings and Precautions

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 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: NSAID's, except aspirin, increases 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.

Indications and Usage
  • temporarily relieves minor aches and pains due to:

o minor pain of arthritis

o muscular aches

o backache

o menstrual cramps

o headache

o toothache

o the common cold



  • temporarily reduces fever
Dosage and Administration

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 cablet every 8 to12 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

Description

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

Section 42229-5

Other information

each caplet contains: sodium 20 mg

store at 20-25ºC (68-77ºF).

Avoid high humidity and excessive heat above 40°C (104°F)

Section 50565-1

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).

Section 50566-9

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
  • 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
Section 50567-7

When using this product

take with food or milk if stomach upset occurs

Section 50568-5

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
Section 50569-3

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
Section 50570-1

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

Section 51945-4

Section 53413-1

Questions or comments? call 1-877-290-4008

Section 53414-9

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.

Section 55105-1

Pain reliever/Fever reducer

Section 55106-9

Naproxen Sodium 220 mg

(naproxen 200 mg)(NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

Indications and Usage (34067-9)
  • temporarily relieves minor aches and pains due to:

o minor pain of arthritis

o muscular aches

o backache

o menstrual cramps

o headache

o toothache

o the common cold



  • temporarily reduces fever
Dosage and Administration (34068-7)

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 cablet every 8 to12 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

Warnings and Precautions (34071-1)

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 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: NSAID's, except aspirin, increases 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.

Section 42229-5 (42229-5)

Other information

each caplet contains: sodium 20 mg

store at 20-25ºC (68-77ºF).

Avoid high humidity and excessive heat above 40°C (104°F)

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(1-800-222-1222).

Section 50566-9 (50566-9)

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
  • 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
Section 50567-7 (50567-7)

When using this product

take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

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
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6 (51727-6)

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? call 1-877-290-4008

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 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.

Section 55105-1 (55105-1)

Pain reliever/Fever reducer

Section 55106-9 (55106-9)

Naproxen Sodium 220 mg

(naproxen 200 mg)(NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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