Label: ALEVE- naproxen sodium tablet
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- NDC Code(s): 67751-144-01, 67751-144-02
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 0280-6000
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 4, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- Uses
-
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 directedDo not use
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgeryAsk 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 asthmaAsk a doctor or pharmacist before use if you are
• under a doctor's care for any serious condition
• taking any other drugWhen 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 directedStop use and ask a 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
- 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
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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- to 12-hour period
- do not exceed 3 caplets in a 24-hour period
Children under 12 years
- ask a doctor
- Other information
- Inacitve Ingredients
- Questions or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ALEVE
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-144(NDC:0280-6000) 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code Aleve Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-144-01 1 in 1 CARTON 09/17/2016 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67751-144-02 1 in 1 CARTON 09/17/2016 2 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020204 09/17/2016 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-144) , repack(67751-144)
