FDA Label for Careall Naproxen
View Indications, Usage & Precautions
Careall Naproxen Product Label
The following document was submitted to the FDA by the labeler of this product New World Imports, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Caplet)
Active ingredient (in each caplet)
Naproxen sodium 220mg
(Naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever / fever reducer
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 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 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 more alcoholic drinks everyday while using this product, take more or for a longer time than directed.
Heart attack and stroke warning: NSAIDs, except aspirin, increase the rist of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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
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.
Ask A Doctor
Ask a doctor before use if:
The stomach bleeding warning applies to you
You ahve a history of stomach problems, such as heartburn
You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
You are taking a diuretic
You have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are:
Under a doctor's care for any serious condition
Taking any other drugs
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
You have symptoms of heart problems or stroke, chest pain, trouble breathing, weakness in one part or side of body, slurred speech, or leg swelling
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
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 (1-800-222-1222).
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
croscarmellose sodium, FD&C blue number 2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
* Please review the disclaimer below.