NDC 0113-2417 Sinus And Cold D

Naproxen Sodium, Pseudoephedrine Hcl

NDC Product Code 0113-2417

NDC CODE: 0113-2417

Proprietary Name: Sinus And Cold D 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 Sodium, Pseudoephedrine Hcl 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Naproxen is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
L417
Score: 1

NDC Code Structure

  • 0113 - L. Perrigo Company

NDC 0113-2417-01

Package Description: 20 BLISTER PACK in 1 CARTON > 1 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Sinus And Cold D with NDC 0113-2417 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Sinus And Cold D is naproxen sodium, pseudoephedrine hcl. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: L. Perrigo Company

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Sinus And Cold D 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
  • PSEUDOEPHEDRINE HYDROCHLORIDE 120 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)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONES (UNII: FZ989GH94E)
  • TALC (UNII: 7SEV7J4R1U)
  • 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.
  • 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: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: ANDA076518 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: 01-29-2015 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.

Sinus And Cold D 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 Ingredients (In Each Caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*Pseudoephedrine HCl 120 mg, extended-release*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducerNasal decongestant

Uses

  • Temporarily relieves these cold, sinus, and flu symptoms: •sinus pressure •minor body aches and pains •headache •nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) •fever

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 •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 more or for a longer time than directed

Do Not Use

  • •if you have ever had an allergic reaction to any other pain reliever/fever reducer •right before or after heart surgery •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. •in children under 12 years of age

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 are taking a diuretic •you have problems or serious side effects from taking pain relievers or fever reducers •you have •asthma •diabetes •thyroid disease •trouble urinating due to an enlarged prostate gland

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 directed

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 •redness or swelling is present in the painful area •any new symptoms appear •fever gets worse or lasts more than 3 days •you have difficulty swallowing or the caplet feels stuck in your throat •you get nervous, dizzy, or sleepless •nasal congestion lasts more than 7 days

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 right away. (1-800-222-1222)

Directions

  • •do not take more than directed •the smallest effective dose should be used •swallow whole; do not crush or chew •drink a full glass of water with each dose •adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours •children under 12 years: do not use

Other Information

  • •each caplet contains: sodium 22 mg •store at 20-25°C (68-77°F) •store in a dry place

Inactive Ingredients

Colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

* Please review the disclaimer below.