Label: ALEVE HEADACHE PAIN- naproxen sodium tablet
-
NDC Code(s):
0280-0041-01,
0280-0041-02,
0280-0041-03,
0280-0041-04, view more0280-0041-05
- Packager: Bayer HealthCare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 6, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purposes:
- 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 directed
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk 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:
-
Ask a Doctor:
- 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 serious side effects from taking pain relievers or fever reducers
- Ask a doctor or pharmacist before use
- When using this product
-
Stop use and ask a doctor
- 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
- 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
- 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
- you experience any of the following signs of stomach bleeding:
- The pregnancy/breast-feeding warning:
- Keep out of reach of children:
-
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 tablet every 8 to 12 hours while symptoms last
- for the first dose you may take 2 tablets within the first hour
- do not exceed 2 tablets in any 8- to 12-hour period
- do not exceed 3 tablets in a 24-hour period
Children under 12 years - ask a doctor
- Other information:
- Inactive ingredient
- Questions & comments:
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 24 Count Tablets
-
INGREDIENTS AND APPEARANCE
ALEVE HEADACHE PAIN
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0041 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color blue Score no score Shape ROUND Size 8mm Flavor Imprint Code ALEVE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0041-01 1 in 1 CARTON 06/01/2021 1 175 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0280-0041-02 1 in 1 CARTON 06/01/2021 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0280-0041-04 1 in 1 CARTON 06/01/2021 3 24 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0280-0041-03 1 in 1 CARTON 06/01/2021 4 90 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0280-0041-05 1 in 1 POUCH; Type 0: Not a Combination Product 06/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020204 06/01/2021 Labeler - Bayer HealthCare LLC (112117283)