DailyMed - NAPROXEN SODIUM tablet, film coated

NDC Code(s): 71335-1061-1, 71335-1061-2, 71335-1061-3, 71335-1061-4, view more
71335-1061-5, 71335-1061-6, 71335-1061-7, 71335-1061-8
Packager: Bryant Ranch Prepack
This is a repackaged label.
Source NDC Code(s): 45802-490

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

Drug Label Information

Updated March 28, 2025

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Official Label (Printer Friendly)

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Active ingredient (in each tablet)
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 ...

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

•

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

•

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 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.

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 tablet ...

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

•

each tablet 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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HOW SUPPLIED
Naproxen Sodium 220mg Tablet - NDC 71335-1061-1: 20 Tablets in a BOTTLE - NDC 71335-1061-2: 30 Tablets in a BOTTLE - NDC 71335-1061-3: 40 Tablets in a BOTTLE - NDC 71335-1061-4: 50 Tablets in a ...
Naproxen Sodium 220mg Tablet
- NDC 71335-1061-1: 20 Tablets in a BOTTLE
- NDC 71335-1061-2: 30 Tablets in a BOTTLE
- NDC 71335-1061-3: 40 Tablets in a BOTTLE
- NDC 71335-1061-4: 50 Tablets in a BOTTLE
- NDC 71335-1061-5: 60 Tablets in a BOTTLE
- NDC 71335-1061-6: 14 Tablets in a BOTTLE
- NDC 71335-1061-7: 100 Tablets in a BOTTLE
- NDC 71335-1061-8: 90 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
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PRINCIPAL DISPLAY PANEL
Naproxen Sodium 220mg Tablet

Naproxen Sodium 220mg Tablet

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INGREDIENTS AND APPEARANCE

Product Information

NAPROXEN SODIUM naproxen sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-1061(NDC:45802-490)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	L490
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-1061-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2021
2	NDC:71335-1061-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2019
3	NDC:71335-1061-3	40 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2021
4	NDC:71335-1061-4	50 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2021
5	NDC:71335-1061-5	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2021
6	NDC:71335-1061-6	14 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2021
7	NDC:71335-1061-7	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2021
8	NDC:71335-1061-8	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074661	04/11/2014

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-1061) , RELABEL(71335-1061)

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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

Published Date (What is this?)	Version	Files
Mar 31, 2025	3 (current)	download
Feb 3, 2022	2	download
Mar 22, 2019	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: NAPROXEN SODIUM tablet, film coated

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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

	NDC
1	71335-1061-1
2	71335-1061-2
3	71335-1061-3
4	71335-1061-4
5	71335-1061-5
6	71335-1061-6
7	71335-1061-7
8	71335-1061-8

Label: 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

NAPROXEN SODIUM tablet, film coated

Number of versions: 3

NAPROXEN SODIUM tablet, film coated

NAPROXEN SODIUM tablet, film coated

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NAPROXEN SODIUM tablet, film coated

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