Naproxen Sodium Capsule, Liquid Filled
FDA Label NDC 51013-137

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Naproxen Sodium (NDC 51013-137). 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 active ingredient (in each capsule), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Capsule)

→ Purposes

→ Uses

→ Warnings

→ 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

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (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

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 If You Are

under a doctor's care for any serious condition
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
  - 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
  - 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

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)
read all directions and warnings before use. Keep carton.

Inactive Ingredients

FD&C blue#1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide, white ink