DailyMed - LEADER ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated

NDC Code(s): 70000-0201-1, 70000-0201-2, 70000-0201-3, 70000-0201-4, view more
70000-0201-5, 70000-0201-6
Packager: Cardinal Health 110, LLC. dba Leader

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 15, 2023

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

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug
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Purposes
Pain reliever/fever reducer

Pain reliever/fever reducer
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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 ...

•

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

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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 ...

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.

Do not use

•

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

•

right before or after heart surgery

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

Ask a doctor or pharmacist before use if you are

•

under a doctor’s care for any serious condition

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taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin

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taking any other drug

When using this product

•

take with food or milk if stomach upset occurs

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

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.

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).

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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 caplet ...

Other information
• each caplet contains: sodium 22 mg - • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

•

each caplet contains: sodium 22 mg

•

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

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Inactive ingredients
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
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Questions or comments?
1-800-719-9260

1-800-719-9260
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Principal Display Panel
LEADER™ All Day Pain Relief - Naproxen Sodium Tablets, 220 mg - Pain Reliever / Fever Reducer (NSAID) Strength to Last 12 Hours - COMPARE TO ALEVE® active ingredient - 100% Money Back Guarantee - Actual ...

LEADER™

All Day Pain Relief

Naproxen Sodium Tablets, 220 mg

Pain Reliever / Fever Reducer (NSAID)

Strength to Last 12 Hours

COMPARE TO ALEVE® active ingredient

100% Money Back Guarantee

Actual Size

90 CAPLETS**

**Capsule-Shaped Tablets

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INGREDIENTS AND APPEARANCE

Product Information

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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

Published Date (What is this?)	Version	Files
Jun 19, 2023	10 (current)	download
Jun 9, 2022	9	download
Sep 23, 2021	8	download
Aug 23, 2021	7	download
Jun 21, 2021	6	download
Dec 11, 2019	5	download
Jun 14, 2018	4	download
Jun 30, 2017	3	download
Feb 22, 2017	2	download
Dec 9, 2016	1	download

	RxCUI	RxNorm NAME	RxTTY
1	849574	naproxen sodium 220 MG Oral Tablet	PSN
2	849574	naproxen sodium 220 MG Oral Tablet	SCD
3	849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY

Label: LEADER ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

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

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	70000-0201-1
2	70000-0201-2
3	70000-0201-3
4	70000-0201-4
5	70000-0201-5
6	70000-0201-6

Label: LEADER ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

LEADER ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated

Number of versions: 10

LEADER ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated

LEADER ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated

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LEADER ALL DAY PAIN RELIEF- naproxen sodium tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.