All Day Pain Relief Naproxen Sodium Tablets, USP 220 mg
Drug Labeling and Warnings
Drug Details [pdf]
ALL DAY PAIN RELIEF NAPROXEN SODIUM- naproxen sodium tablet
Camber Consumer Care
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All Day Pain Relief Naproxen Sodium Tablets, USP 220 mg
Active ingredient (in each tablet)
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
- blisters
- skin reddening
- rash
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
- 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
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
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 to 12 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).
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088
| ALL DAY PAIN RELIEF NAPROXEN SODIUM
naproxen sodium tablet |
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| Labeler - Camber Consumer Care (079539968) |
| Registrant - Camber Consumer Care (079539968) |
Revised: 6/2019
Document Id: d7ca5c25-45cd-4623-9452-8f86c7976a5a
Set id: dc0f8bfc-669a-40b8-81e4-b9492a7b617c
Version: 2
Effective Time: 20190612
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