Active ingredient(in each capsule)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- minor pain of arthritis
- toothache
- backache
- the common cold
- menstrual cramps
- 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 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 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
- stomach pain or upset gets worse or lasts
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
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
- drink a full glass of water with each dose
- if taken with food, this product may take longer to work
Adults and children 12 years and older: |
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Children under 12 years |
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Other information
- each capsule contains:sodium 20 mg
- store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).
- do not use if carton is open or if Tamper-Evident seal under bottle cap imprinted with “Sealed for Your Protection” is broken or missing.
- do not use if Tamper-Evident seal under bottle cap is broken or missing.
- read all directions and warnings before use. Keep carton.
Inactive ingredients FD&C Blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Manufactured by:
Banner Pharmacaps Inc.
4125 Premier Drive
High Point, NC 27265
Principal Display Panel-Shipping Label
NDC 10888-7121
Naproxen sodium, 220 mg
(Liquid Filled Capsules)
6,000 Softgels
IMPORTANT
This bulk shipment, is intended for further processing only. It is not to be used in its present condition, and it should be re-packaged immediately, and labeled strictly in conformance with the FD&C Act and regulations. Store below 60% relative humidity at 59°-86°F (15°-30°C)-do not refrigerate.
CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING ONLY
BANNER PHARMACAPS INC. BULK LABEL
| NAPROXEN SODIUM naproxen sodium capsule, liquid filled | ||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021920 | 03/01/2007 | |
| Labeler - Banner Pharmacaps Inc. (002193829) |
More Naproxen Capsules resources
- Naproxen Capsules Side Effects (in more detail)
- Naproxen Capsules Use in Pregnancy & Breastfeeding
- Drug Images
- Naproxen Capsules Drug Interactions
- Naproxen Capsules Support Group
- 131 Reviews for Naproxen - Add your own review/rating
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