NDC 70729-003 Naproxen Sodium Caplets

NDC Product Code 70729-003

NDC 70729-003-24

Package Description: 24 TABLET in 1 BOTTLE, PLASTIC

NDC 70729-003-50

Package Description: 50 TABLET in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Naproxen Sodium Caplets with NDC 70729-003 is a product labeled by Breeden Brothers, Llc. The generic name of Naproxen Sodium Caplets is . The product's dosage form is and is administered via form.

Labeler Name: Breeden Brothers, Llc

Dosage Form: -

Product Type: 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.

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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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

Labeler Name: Breeden Brothers, Llc
Labeler Code: 70729
Start Marketing Date: 02-01-2017 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: 12-31-2019 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: I 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.

Information for Patients

Naproxen

Naproxen is pronounced as (na prox' en)

Why is naproxen medication prescribed?
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints),...
[Read More]

* Please review the disclaimer below.

Naproxen Sodium Caplets 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 (In Each Caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

Uses

_ temporarily relieves minor aches and pains due to:_ toothache _ muscular aches _ the common cold_ headache _ menstrual cramps_ backache _ minor pain of arthritis_ temporarily reduces feverDrug Facts (continued)

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:_ asthma (wheezing) _ skin reddening _ shock_ blisters _ rash _ facial swelling _ hivesIf 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 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 a blood thinning (anticoagulant) or steroid drug_ take more or for a longer time than directedDrug Facts (continued)

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, or kidney disease _ you have asthma_ you have problems or serious side effects from taking pain relievers or fever reducers_ you are taking a diuretic

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_ the risk of heart attack or stroke may increase if you use more than directed or for longer than directedDrug Facts (continued)

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_ 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

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 (1-800-222-1222) right away.Drug Facts (continued)

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- to 12-hour period_ do not exceed 3 caplets in a 24-hour period_ children under 12 years: ask a doctor

Other Information

_ each caplet contains: sodium 20 mg_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN_ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)_ use by expiration date on packageDrug Facts (continued)

Inactive Ingredients

Croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

* Please review the disclaimer below.