NDC 49035-982 Allergy Relief-d

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride

NDC Product Code 49035-982

NDC Code: 49035-982

Proprietary Name: Allergy Relief-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: Cetirizine 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)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
915
Score: 1

NDC Code Structure

  • 49035 - Equate (wal-mart Stores, Inc.)
    • 49035-982 - Allergy Relief-d

NDC 49035-982-24

Package Description: 4 BLISTER PACK in 1 CARTON > 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Allergy Relief-d with NDC 49035-982 is a a human over the counter drug product labeled by Equate (wal-mart Stores, Inc.). The generic name of Allergy Relief-d is cetirizine hydrochloride and pseudoephedrine hydrochloride. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Equate (wal-mart Stores, 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.

Allergy Relief-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.

  • CETIRIZINE HYDROCHLORIDE 5 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.

  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • AMMONIA (UNII: 5138Q19F1X)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)

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: Equate (wal-mart Stores, Inc.)
Labeler Code: 49035
FDA Application Number: ANDA090922 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: 05-31-2019 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.

Allergy Relief-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

Other

Drug Facts

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Otc - Purpose

Active ingredients (in each extended-release tablet)PurposeCetirizine HCl, USP 5 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 nose or throatnasal congestionreduces 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 ingredients or to an antihistamine containing hydroxyzine.if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain 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.

Ask A Doctor Before Use If You Have

  • Heart diseasethyroid diseasediabetesglaucomahigh blood pressuretrouble urinating due to an enlarged prostate glandliver or kidney disease. Your doctor should determine if you need a different dose.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When Using This Product

  • Do not use more than directeddrowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding

  • If breast-feeding: not recommendedif pregnant: 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 at 1-800-222-1222.

Directions

  • Do not break or chew tablet; swallow tablet wholeadults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Other Information

  • Store between 20° to 25°C (68° to 77°F)do not use if carton is opened or if the blister unit is brokensee side panel for batch number and expiration date

Inactive Ingredients

Hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Imprinting Ink Contents

Ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

Questions?

1-888-287-1915

* Please review the disclaimer below.

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