NDC 56062-999 Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

NDC Product Code 56062-999

NDC Code: 56062-999

Proprietary Name: Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride 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: Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride 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):
WHITE (C48325)
YELLOW (C48330)
Shape: CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
724
Score: 1

NDC Code Structure

  • 56062 - Publix Super Markets Inc
    • 56062-999 - Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

NDC 56062-999-30

Package Description: 1 BLISTER PACK in 1 CARTON > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride with NDC 56062-999 is a a human over the counter drug product labeled by Publix Super Markets Inc. The generic name of Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride is fexofenadine hydrochloride and pseudoephedrine hydrochloride. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Publix Super Markets Inc

Dosage Form: Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.

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.

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride 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.

  • FEXOFENADINE HYDROCHLORIDE 60 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.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • POVIDONE K30 (UNII: U725QWY32X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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: Publix Super Markets Inc
Labeler Code: 56062
FDA Application Number: ANDA090818 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: 04-01-2019 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.

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Product Label Images

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride 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

DISTRIBUTED BYPUBLIX SUPER MARKETS, INC.,3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

Otc - Purpose

Active ingredients (in each extended-release tablet)PurposeFexofenadine HCl, USP 60 mgAntihistaminePseudoephedrine HCl, USP 120 mgNasal Decongestant

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throattemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiesreduces swelling of nasal passagestemporarily relieves sinus congestion and pressuretemporarily restores freer breathing through the nose

Do Not Use

  • If you have ever had an allergic reaction to this product or any of its ingredientsif 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.if you have difficulty swallowing

Ask A Doctor Before Use If You Have

  • Heart diseasethyroid diseaseglaucomahigh blood pressurediabetestrouble urinating due to an enlarged prostate glandkidney disease. Your doctor should determine if you need a different dose.

When Using This Product

  • Do not take more than directeddo not take at the same time as aluminum or magnesium antacidsdo not take with fruit juices (see Directions)

Stop Use And Ask A Doctor If

  • An allergic reaction to this product occurs. Seek medical help right away.symptoms do not improve within 7 days or are accompanied by a feveryou get nervous, dizzy, or sleepless

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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 divide, crush, chew or dissolve the tablet; swallow tablet wholeadults and children 12 years of age and overtake 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor

Other Information

  • Do not use if carton is opened or if individual blister units are torn or openedstore between 68° to 77°F (20° to 25°C)USP dissolution test is pending.

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

* Please review the disclaimer below.

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