Label: CAREALL NAPROXEN SODIUM- naproxen sodium tablet
- NDC Code(s): 51824-109-01
- Packager: New World Imports, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 23, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
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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
Do not use:
If you have ever had an allergic reaction to any other pain reliever/fever reducer.
Right before or after heart surgery
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, kidney disease, asthma, or had a stroke
you are taking a diuretic
You have problems or serius side effects from taking pain relievers or fever reducers
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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
- Keep out of reach of Children
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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
- Other Information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-109 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) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code 17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-109-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/23/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079096 08/23/2024 Labeler - New World Imports, Inc. (075372276)