NDC 62011-0396 Naproxen Sodium Pm

Naproxen Sodium

NDC Product Code 62011-0396

NDC Code: 62011-0396

Proprietary Name: Naproxen Sodium Pm Additional informationCallout TooltipWhat 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 Sodium Additional informationCallout TooltipWhat 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: CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
AC37
Score: 1

Code Structure
  • 62011 - Mckesson (health Mart)
    • 62011-0396 - Naproxen Sodium Pm

NDC 62011-0396-1

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 20 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Naproxen Sodium Pm with NDC 62011-0396 is a a human over the counter drug product labeled by Mckesson (health Mart). The generic name of Naproxen Sodium Pm is naproxen sodium. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Mckesson (health Mart)

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Naproxen Sodium Pm Active Ingredient(s)

Additional informationCallout TooltipWhat 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
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POVIDONE (UNII: FZ989GH94E)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mckesson (health Mart)
Labeler Code: 62011
FDA Application Number: ANDA209726 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Naproxen Sodium Pm Product Label Images

Naproxen Sodium Pm 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)

Diphenhydramine hydrochloride 25 mgNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)**nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aidPain reliever

Uses

  • For relief of occasional sleeplessness when associated with minor aches and painshelp you fall asleep and stay asleep

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
  • BlistersIf 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 directedHeart 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 reducerunless you have time for a full night's sleepin children under 12 years of ageright before or after heart surgery with any other product containing diphenhydramine, even one used on skinif you have sleeplessness without pain

Ask A Doctor Before Use If

  • The stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reduceryou 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 a breathing such as emphysema or chronic bronchitisyou have glaucomayou have trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizer, or any other sleep-aidunder a doctor’s care for any serious condition taking any other antihistaminestaking any other drug

When Using This Product

  • Drowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinerytake 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 betteryou have symptoms of heart problems or strokechest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or last more than 10 dayssleeplessness persists continuously for more than 2 weeks insomnia may be a symptom of a serious underlying medical illness.redness or swelling is present in the painful areaany new symptoms appear you have difficulty swallowingit feels like the pill 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 (1-800-222-1222) right away.

Directions

  • Do not take more than directeddrink a full glass of water with each dose
  • Adults and children 12 years and over:take 2 tablets at bedtimedo not take more than 2 tablets in 24 hours if taken with food, this product may take longer to work

Other Information

  • Each tablet contains: sodium 20 mgread all warnings and directions before use. Keep carton.store between 20º- 25ºC (68º-77ºF)avoid high humidity and excessive heat above 40ºC (104ºF)

Inactive Ingredients

Carnauba wax, FD&C blue #2, aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Product Label

HEALTH MART Naproxen PM

* Please review the disclaimer below.

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