CAREALL Naproxen description, usages, side effects, indications, overdosage, supplying and lots more!

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CAREALL Naproxen

NEW WORLD IMPORTS, INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Naproxen 200mg

Purpose

Pain reliever / fever reducer

CAREALL Naproxen Uses

Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, common cold, temporarily reduces fever

Warnings

Allergy alert:  Naproxen sodium may casue 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 NSAID, which may casue 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 mre alcoholic drinks everyday while using this product, take more or for a longer time than directed. 

Do not use

Do not use:

If you have ever had an allergic reaction to any other pain reliever/fever reducer.

Right before or after heart surgery

When using this product

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 of for longer than directed

Ask a Doctor

Ask a doctor before use if:

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 paiin relievers or fever reducers

You have asthma

Ask a doctor or pharmacist before use if you are:

under a doctors care for any serious condition

Taking any other drug

Stop use and ask a doctor

Stop use and ask a doctor if:

You experience any of the following signs of stomach bleeding: you feel faint, vomit blood, have bloddy 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, redness or swelling is present in the painful area, or any new symptoms appear.

If pregnant or breast-feeding

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 definately 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


Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

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 caplet every 8 to 12 hours while symptoms last
  • For the first dose you may take 2 caplets within the first hour
  • Do not exceed 2 caplets in any 8 - 12 hour period
  • Do not exceed 3 caplets in a 24 hour period

Children under 12 years: ask a doctor

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD and C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

CAREALL Naproxen

CAREALL Naproxen

Naproxen Sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51824-030
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
povidone
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
blue 12 mm 144 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51824-030-01 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 2013-05-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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