RxNorm Names
Review RxNorm Normal Forms
GOOD SENSE ALL DAY PAIN RELIEF
(naproxen sodium)
tablet, film coated
[Bryant Ranch Prepack]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=17f48eda-e036-0673-800f-ca4ef0150059| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN PRESCRIPTION DRUG LABEL | Abbreviated New Drug Application |
Active ingredient (in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- minor pain of 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 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 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
- 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
- you develop heartburn
- redness or swelling is present in the painful area
- any new symptoms appear
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 |
|
Other information
- each caplet contains: sodium 20 mg
- store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
| GOOD SENSE ALL DAY PAIN RELIEF
naproxen sodium tablet, film coated |
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| Labeler - Bryant Ranch Prepack (171714327) |
| Registrant - Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Bryant Ranch Prepack | 171714327 | REPACK(63629-1793), RELABEL(63629-1793) | |
Revised: 01/1997
Document Id: 5585711c-4a25-4b91-ab53-3fd2ff096054
Set id: 17f48eda-e036-0673-800f-ca4ef0150059
Version: 3
Effective Time: 19970114
Bryant Ranch Prepack
