RxNorm Names
Review RxNorm Normal Forms
HEALTHY ACCENTS NAPROXEN SODIUM
(naproxen sodium)
tablet, film coated
[DZA Brands LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cf68585a-1b4e-4539-b3da-00071ece498e| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
Active ingredient (in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
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- temporarily relieves minor aches and pains due to:
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- minor pain of arthritis
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- muscular aches
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- backache
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- menstrual cramps
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- headache
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- toothache
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- the common cold
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- temporarily reduces fever
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- the stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
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- 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
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- 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
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- you have difficulty swallowing
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- it feels like the pill is stuck in your throat
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- redness or swelling is present in the painful area
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- any new symptoms appear
Directions
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- do not take more than directed
- •
- the smallest effective dose should be used
- •
- 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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Other information
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- each caplet contains: sodium 21 mg
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- store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
| HEALTHY ACCENTS NAPROXEN SODIUM
naproxen sodium tablet, film coated |
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| Labeler - DZA Brands LLC (090322194) |
Revised: 12/2012
Document Id: cf68585a-1b4e-4539-b3da-00071ece498e
Set id: cf68585a-1b4e-4539-b3da-00071ece498e
Version: 1
Effective Time: 20121219
DZA Brands LLC
