NAPROXEN SODIUM (NSAID) FEVER REDUCER/ PAIN RELIEVER
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naproxen sodium tablet
Amneal Pharmaceuticals
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Naproxen Sodium Tablets, USP (NSAID)Pain Reliever/ Fever Reducer
220 mg
Compared to the active ingredient of Aleve® †
Drug Facts
ACTIVE INGREDIENT
(in each Tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
PURPOSE
Pain reliever/fever reducer
USES
- temporarily relieves minor aches and pains due to:
- minor pain or 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 NSAID (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 you have
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- high blood pressure
- heart or kidney disease
- taken a diuretic
- reached age 60 or older
Ask a doctor or pharmacist before use if you are
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- 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
- long term continuous use ay increase the risk of heart attack or stroke
Stop use and ask a doctor if
- you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
- 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
- you develop heartburn
- stomach pain or upset gets worse or lasts
- 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
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
- drink a full glass of water with each dose
| Adults and children 12 years and older |
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| Children under 12 years |
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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)
Inactive ingredients
FD&C Blue #2, croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide.
Questions or Comments?
Call 1-877-835-5472
Monday though Friday 9AM – 5PM EST.
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
†This product is not manufactured or distributed by Bayer Healthcare, LLC., distributor of Aleve®
Rev. 09-2008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
| NAPROXEN SODIUM (NSAID)
FEVER REDUCER/ PAIN RELIEVER
naproxen sodium tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA079096 | 11/25/2009 | |
| NAPROXEN SODIUM (NSAID)
FEVER REDUCER/ PAIN RELIEVER
naproxen sodium tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA079096 | 11/25/2009 | |
| Labeler - Amneal Pharmaceuticals (831227801) |
| Registrant - Amneal Pharmaceuticals (831227801) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Amneal Pharmaceuticals | 831227801 | ANALYSIS, MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Integrated Pharmaceutical Packaging | 829375455 | RELABEL, REPACK | |