Naproxen Sodium NAPROXEN SODIUM CVS FDA Approved 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
Generic: NAPROXEN SODIUM
Mfr: CVS FDA OTC
FunFoxMeds box
Substance Naproxen Sodium
Route
ORAL
Applications
ANDA091353
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient ​(in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)** **nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive Ingredients FD&C blue#2 aluminum lake hypromellose 2910 maize starch microcrystalline cellulose polyethylene glycol povidone k-30 sodium starch glycolate stearic acid titanium dioxide
Strengths
220 mg 200 mg
Treats Conditions
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
Pill Appearance
Shape: oval Color: blue Imprint: 220

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
9TN87S3A3C
Packaging

Principal display panel 270

Package Descriptions
  • Principal display panel 270

Overview

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

Indications & Usage

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

Dosage & Administration

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- to12-hour period  do not exceed 3 caplets in a 24-hour period Children under 12 years  ask a doctor

Warnings & Precautions
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 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.
Purpose

Purposes Pain reliever/fever reducer

Do Not Use

Do not use  if you have ever had an allergic reaction to any other pain reliever/fever reducer  right before or after heart surgery

When Using

When Using this Product  take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

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  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

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.

Storage & Handling

Other information  each caplet contains: sodium 20 mg  store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Questions

Questions or Comments? call 1-877-770-3183 Mon – Fri 8:00 AM to 5:00 PM PST.


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