Label: CAREALL NAPROXEN- naproxen sodium capsule
- NDC Code(s): 51824-030-01
- Packager: New World Imports, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 22, 2018
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- Active ingredients (in each tablet)
Pain reliever / fever reducerClose
Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, common cold, temporarily reduces feverClose
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.
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
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, you have symptoms of heart problems or stroke, chest pain, trouble breathing, weakness in one part or side of body, slurred speech, leg swelling, 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, or any new symptoms appear.Close
- 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 deliveryClose
- 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.
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 doctorClose
- Inactive ingredients
FD and C blue number 2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide. May contain: corn starch, croscarmellose sodium, magnesium stearate, purified water, silicon dioxide, sodium starch glycolate, stearic acidClose
- INGREDIENTS AND APPEARANCE
naproxen sodium capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-030 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) water (UNII: 059QF0KO0R) starch, corn (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code 144 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-030-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 05/01/2013 Labeler - New World Imports, Inc. (075372276)