NDC 0363-9609 Back And Muscle Pain

Naproxen

NDC Product Code 0363-9609

NDC Code: 0363-9609

Proprietary Name: Back And Muscle Pain What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Naproxen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
141
Score: 1

NDC Code Structure

NDC 0363-9609-01

Package Description: 100 TABLET, COATED in 1 BOTTLE

NDC 0363-9609-42

Package Description: 24 TABLET, COATED in 1 BOTTLE

NDC Product Information

Back And Muscle Pain with NDC 0363-9609 is a a human over the counter drug product labeled by Walgreens. The generic name of Back And Muscle Pain is naproxen. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Walgreens

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Back And Muscle Pain Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NAPROXEN SODIUM 220 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreens
Labeler Code: 0363
FDA Application Number: ANDA090545 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-03-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Back And Muscle Pain Product Label Images

Back And Muscle Pain Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Naproxen Sodium Tablets, USP

220 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

Purpose

Pain reliever/ fever reducer

Indications & Usage

Temporarily relieves minor aches and pain due to:backache

muscular aches

minor pain of arthritis

menstrual cramps

headache

toothache

the common cold
temporarily reduces fever

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 to12 hours while symptoms last

for first dose you may take 2 tablets with in 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

Otc - Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a poison control center right away.

Warnings

Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

asthma (wheezing)

blisters

facial swelling

hives

rash

shock

skin reddening

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 bad stomach ulcers or bleeding problems

take blood thinning (anticoagulant) or steroid drug

take other drug 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: NSAID's, except aspirin, increases 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.

* Please review the disclaimer below.