OTC Medication Information: Naproxen Sodium

NAPROXEN SODIUM- naproxen sodium capsule, liquid filled
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed

Heart attack and stroke: 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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • slurred speech
    • leg swelling
    • trouble breathing
    • weakness in one part or side of body
  • 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 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222).

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.
  • swallow whole; do not crush, chew, or dissolve

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, sorbitan, sorbitol solution, titanium dioxide, white ink

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredient in Aleve®

Naproxen Sodium

Capsules, 220 mg (NSAID)*

Pain Reliever; Fever Reducer

Liquid-filled Capsules

This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Label

Naproxen Sdium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
(click image for full-size original)

DOLLAR GENERAL HEALTH Naproxen Sodium Capsules 220 mg

NAPROXEN SODIUM
naproxen sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-748
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
LACTIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITAN
SORBITOL
LECITHIN, SOYBEAN
LIGHT MINERAL OIL
ALCOHOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code PC19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-748-20 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (55910-748-20)
2 NDC:55910-748-40 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
2 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (55910-748-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208363 04/01/2018
Labeler — Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 12/2019 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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