Label: ALEVE- naproxen sodium tablet
- NDC Code(s): 67751-144-03, 67751-144-04, 67751-144-05
- 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 March 1, 2023
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)
- Purposes
- Uses
-
Warnings
Allergy alert
Naproxen sodium may cause a severe allergic reaction, especialy in people allergic to asprin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blister
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 chace 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, napoxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time 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 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
-
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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 12 POUCH DISPENSIT
-
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 HYPROMELLOSES (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 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:67751-144-03 1 in 1 CARTON 12/04/2017 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67751-144-04 2 in 1 CARTON 12/04/2017 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:67751-144-05 12 in 1 TRAY 12/04/2017 11/30/2024 3 1 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 12/04/2017 Labeler - Navajo Manufacturing Company Inc (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc 136941411 relabel(67751-144) , repack(67751-144)
