Naproxen Sodium Capsule, Liquid Filled
FDA Label NDC 46122-780

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Naproxen Sodium (NDC 46122-780). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each capsule), purposes, uses, warnings, heart attack and stroke warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients (in Each Capsule)

→ Purposes

→ Uses

→ Warnings

→ Heart Attack And Stroke Warning

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 20's Carton

Other

Drug Facts

Do not use if printed safety seal under cap is torn or missing.

***This product is not manufactured or distributed by the owners of ALEVE ® Liquid Gels.

Distributed By
AmerisourceBergen
1 West First Ave
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com
ABC#: 10287376 Rev: 04/24

T00026R0621

L0000782

R0224

Lot No.:
Exp. Date:

Active Ingredients (In Each Capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces fever

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

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

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, 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 If You Are

under a doctor's care for any serious condition
taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
taking any other drug

When Using This Product

take with food or milk if stomach upset occurs

Stop 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
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
slurred speech
weakness in one part or side of body
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
any new symptoms appear
you have difficulty swallowing
it feels like the capsule is stuck in your throat

If Pregnant Or Breast-Feeding,

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
if taken with food, this product may take longer to work

adults and children 12 years and older:	take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period
children under 12 years:	ask a doctor

Other Information

each capsule contains:sodium 20 mg
store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
protect from light
read all directions and warnings before use. Keep carton.

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol