PROXEN NP 660- naproxen sodium tablet

PROXEN NP 660 by

Drug Labeling and Warnings

PROXEN NP 660 by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet) Purposes

Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

Uses

■ temporarily relieves minor aches and pains due to:

■ headache ■ backache ■ muscular aches

■ the common cold ■ toothache ■ menstrual cramps

■ minor pain of arthritis ■ temporarily reduces fever

Warnings

Allergy alert:

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives ■ asthma (wheezing) ■ skin reddening

■ facial swelling ■ shock ■ 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

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, or kidney disease

■ you are taking a diuretic

■ you have problems or serious side effects from taking pain relievers or fever reducers

■ you have asthma

Ask a doctor or pharmacist before use if you are

■ under a doctor's care for any serious condition

■ taking any other drug

When using this product

■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

■ side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

■ 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

■ 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.

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 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 to12 hour period

■ do not exceed 3 tablets in a 24 hour period

Children under 12 years

■ ask a doctor

Other information

■ each tablet 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 product information before using

■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9AM – 5PM EST) or https://www.opmx.us

PRINCIPAL DISPLAY PANEL 12 CAPLETS

NDC: 69729-123-12

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

12 Caplets

PRINCIPAL DISPLAY PANEL 24 CAPLETS

NDC: 69729-123-24

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

24 Caplets

PRINCIPAL DISPLAY PANEL 100 CAPLETS

NDC: 69729-123-50

PROXEN NP 660

NAPROXEN SODIUM

Arthritis/Artritis

Backache/Dolor de Espalda

Muscle and Joint Pain/ Dolor Muscular y de Articulaciones

100 Caplets

INGREDIENTS AND APPEARANCE

PROXEN NP 660 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-123
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	OVAL (Capsule-Shaped)	Size	12mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-123-12	1 in 1 CARTON	11/07/2023
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69729-123-24	2 in 1 CARTON	11/16/2023
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 69729-123-50	50 in 1 CARTON	11/07/2023
3		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091353	11/07/2023

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		860316511	manufacture(69729-123) , label(69729-123) , pack(69729-123)