Search by Drug Name or NDC

NDC 62011-0369-01 Naproxen Sodium 220 mg/1 Details

Naproxen Sodium 220 mg/1

Naproxen Sodium is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is NAPROXEN SODIUM.

MedlinePlus Drug Summary

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 62011-0369-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naproxen

Product Information

NDC	62011-0369
Product ID	62011-0369_aed611bf-fb01-46af-a2fb-359f4379e5a5
Associated GPIs	66100060100127
GCN Sequence Number	066844
GCN Sequence Number Description	naproxen sodium CAPSULE 220 MG ORAL
HIC3	S2B
HIC3 Description	NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
GCN	29254
HICL Sequence Number	003726
HICL Sequence Number Description	NAPROXEN SODIUM
Brand/Generic	Generic
Proprietary Name	Naproxen Sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naproxen Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	220
Active Ingredient Units	mg/1
Substance Name	NAPROXEN SODIUM
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208363
Listing Certified Through	2024-12-31

Package

Package Images

NDC 62011-0369-01 (62011036901)

Pricing Information
NDC Package Code	62011-0369-1
Billing NDC	62011036901
Package	1 BOTTLE, PLASTIC in 1 BOX (62011-0369-1) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-04-01
NDC Exclude Flag	N
Price Per Unit	0.156
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	HM NAPROXEN SODIUM 220 MG CAP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL a636037d-127c-478d-9d61-dda6eafd2e81 Details

Active ingredient (in each capsule)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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
have 3 or more alcoholic drinks every day while using this product
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
take more or for a longer time than directed

Heart attack and stroke: 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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- leg swelling
- slurred speech
- 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
redness or swelling is present in the painful area
any new symptoms appear
you have difficulty swallowing
it feels like the capsule is stuck in your throat

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 (1-800-222-1222) right away.

Directions

do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
if taken with food, this product may take longer to work
adults and children 12 years and older
- take 1 capsule every 8 to 12 hours while symptoms last
- for the first dose you may take 2 capsules within the first hour
- do not exceed 2 capsules in any 8- to 12-hour period
- do not exceed 3 capsules in a 24-hour period
children under 12 years: ask a doctor

Other information

each capsule contains: sodium 20 mg
store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
read all directions and warnings before use. Keep carton.
swallow whole; do not crush, chew, or dissolve

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone K30, propylene glycol, purified water, shellac glaze, sorbitan, sorbitol solution, titanium dioxide, white ink

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Aleve®†

Naproxen Sodium Capsules, 220 mg

Pain Reliever/Fever Reducer (NSAID)

Strength to Last 12 Hours

Liquid Gels**

(**Liquid-filled capsules)

†This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve®

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

healthmart.com

Product Label

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

HEALTH MART Naproxen Sodium 220 mg

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM

naproxen sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62011-0369
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. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	PC19
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62011-0369-1	1 in 1 BOX	04/01/2018
1		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208363	04/01/2018

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 11/2022

Document Id: aed611bf-fb01-46af-a2fb-359f4379e5a5

Set id: a636037d-127c-478d-9d61-dda6eafd2e81

Version: 7

Effective Time: 20221115