NDC 62732-1026 Naproxen Sodium Caplets

NDC Product Code 62732-1026

NDC 62732-1026-1

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET in 1 BOTTLE

NDC 62732-1026-2

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET in 1 BOTTLE

NDC 62732-1026-3

Package Description: 1000 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

NDC Product Information

Naproxen Sodium Caplets with NDC 62732-1026 is a product labeled by Yichang Humanwell Pharmaceutical Co., Ltd.. The generic name of Naproxen Sodium Caplets is . The product's dosage form is and is administered via form.

Labeler Name: Yichang Humanwell Pharmaceutical Co., Ltd.

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.

  • POVIDONE K30 (UNII: U725QWY32X)
  • MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TALC (UNII: 7SEV7J4R1U)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Labeler Information

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

Labeler Name: Yichang Humanwell Pharmaceutical Co., Ltd.
Labeler Code: 62732
Start Marketing Date: 12-31-2020 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: E 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.

Naproxen Sodium Caplets Product Label Images

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

Other

Drug Facts

Active Ingredient (In Each Caplet)

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 arthritismuscular achesbackachemenstrual crampsheadachetoothachethe common coldtemporarily reduces fever

Allergy Alert

  • Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake 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.

Do Not Use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery

Ask A Doctor Before Use If

  • The stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney disease, asthma, or had a strokeyou are taking a diureticyou 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 conditiontaking any other drug

When Using This Product

  • Take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If

  • Side effects occur. You may report side effects to FDA at
  • 1-800-FDA-1088.
  • You experience any of the following signs of stomach bleeding:    o feel faint    o vomit blood    o have bloody or black stools    o have stomach pain that does not get betteryou have symptoms of heart problems or stroke:    o chest pain
  • O trouble breathing
  • O weakness in one part or side of body
  • O slurred speech
  • O leg swelling
  • Pain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysyou have difficulty swallowingit feels like the pill is stuck in your throatredness or swelling is present in the painful areaany new symptoms appear

Otc - Pregnancy Or Breast Feeding

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.

Otc - 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. (1-800-222-1222)

Directions

  • Do not take more than directedthe smallest effective dose should be useddrink a full glass of water with each doseAdults and children 12 years and oldertake 1 caplet every 8 to 12 hours while symptoms lastfor the first dose you may take 2 caplets within the first hourdo not exceed 2 caplets in any 8- to 12-hour perioddo not exceed 3 caplets in a 24-hour periodChildren under 12 yearsask a doctor

Other Information

  • Each caplet contains: sodium 21 mg
  • Store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients

Croscarmellose sodium, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide.

* Please review the disclaimer below.