FDA Label for Proxen Np 660
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- ALLERGY ALERT:
- STOMACH BLEEDING WARNING:
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL 12 CAPLETS
- PRINCIPAL DISPLAY PANEL 24 CAPLETS
Proxen Np 660 Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
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
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
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
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
* Please review the disclaimer below.