NAPROXEN SODIUM- naproxen sodium tablet, coatedMarksans Pharma Limited
Drug Labeling and Warnings
Drug Details [pdf]
ALL DAY RELIEF- naproxen sodium tablet, coated tablet
Rugby Laboratories
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NAPROXEN SODIUM- naproxen sodium tablet, coated
Marksans Pharma Limited
Active ingredient(s)
Naproxen Sodium Tablets, USP
220 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Use(s)
temporarily relieves minor aches and pain due to:
- backache
- headache
- menstrual cramps
- minor pain of arthritis
- muscular aches
- the common cold
- toothache
- temporarily reduces fever
Warnings
Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
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 bad stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drug 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
- 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 doctor if
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you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have a stomach pain that dose 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 sluck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
Pregnancy/Breastfeeding
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of the 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 accidental overdose, get medical help or contact a poison control center right away.
Directions
- do not more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directred by a doctor (see Warnings)
- drink a full glass of water with each dose
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Adults and children 12 years and older:
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children under 12 years:
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| Labeler - Rugby Laboratories (079246066) |
Revised: 9/2019
Document Id: 138470c6-e554-4cfe-8d3a-111755672429
Set id: 05cf0ab1-293c-4740-84b8-9a4a1cc3e9d9
Version: 2
Effective Time: 20190906
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