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NDC 00280-6092-10 Aleve Back and Muscle Pain 220 mg/1 Details

Aleve Back and Muscle Pain 220 mg/1

Aleve Back and Muscle Pain is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bayer HealthCare 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: 00280-6092-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen

Product Information

NDC	00280-6092
Product ID	0280-6092_e9325493-7c3f-e9f2-e053-2995a90a89b6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Aleve Back and Muscle Pain
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naproxen Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	220
Active Ingredient Units	mg/1
Substance Name	NAPROXEN SODIUM
Labeler Name	Bayer HealthCare LLC.
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA020204
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00280-6092-10 (00280609210)

Pricing Information	N/A
NDC Package Code	0280-6092-10
Billing NDC	00280609210
Package	1 BOTTLE in 1 CARTON (0280-6092-10) / 100 TABLET in 1 BOTTLE
Marketing Start Date	2018-01-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6376e1b8-52c4-0519-e053-2a91aa0af35f Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg)

(NSAID)*

*nonsteroidal anti-inflammatory drug

SPL UNCLASSIFIED SECTION

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- backache
- muscular aches
- minor pain of arthritis
- menstrual cramps
- headache
- toothache
- the common cold
temporarily reduces fever

SPL UNCLASSIFIED SECTION

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 tablets 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

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED SECTION

Inactive ingredients FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

SPL UNCLASSIFIED SECTION

Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

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Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

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In case of overdose, get medical help or contact a Poison Control Center right away.

Package label display

All Day Strong®

Aleve®

Back & Muscle Pain

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of minor back and muschle aches and pains

ACTUAL SIZE

Strength to Last 12 Hours 24Tablets

INGREDIENTS AND APPEARANCE

ALEVE BACK AND MUSCLE PAIN

naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0280-6092
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	ALEVE
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0280-6092-24	1 in 1 CARTON	01/26/2018
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0280-6092-50	1 in 1 CARTON	01/26/2018
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:0280-6092-10	1 in 1 CARTON	01/26/2018	09/30/2023
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:0280-6092-25	1 in 1 CARTON	08/06/2019
4		250 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:0280-6092-02	1 in 1 CARTON	01/26/2018
5		130 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:0280-6092-04	1 in 1 CARTON	01/26/2018
6		200 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:0280-6092-05	1 in 1 CARTON	01/26/2018
7		225 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:0280-6092-06	1 in 1 CARTON	01/26/2018	03/31/2022
8		36 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:0280-6092-07	1 in 1 CARTON	01/26/2018	11/30/2021
9		65 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:0280-6092-08	1 in 1 CARTON	07/01/2021
10		250 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:0280-6092-09	1 in 1 CARTON	07/01/2021
11		90 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC:0280-6092-12	10 in 1 VIAL; Type 0: Not a Combination Product	07/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020204	01/26/2018

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2022

Document Id: e9325493-7c3f-e9f2-e053-2995a90a89b6

Set id: 6376e1b8-52c4-0519-e053-2a91aa0af35f

Version: 18

Effective Time: 20220921

Search by Drug Name or NDC

NDC 00280-6092-10 Aleve Back and Muscle Pain 220 mg/1 Details

Aleve Back and Muscle Pain 220 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00280-6092-10 (00280609210)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6376e1b8-52c4-0519-e053-2a91aa0af35f Details

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Uses

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Package label display

INGREDIENTS AND APPEARANCE

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