NDC 21130-784 Allergy Relief

Fexofenadine Hydrochloride

NDC Product Code 21130-784

NDC CODE: 21130-784

Proprietary Name: Allergy Relief 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 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.

  • Diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose, and sneezing. It is also used to prevent and treat nausea, vomiting and dizziness caused by motion sickness. Diphenhydramine can also be used to help you relax and fall asleep. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Product Characteristics

PINK (C48328)
Shape: OVAL (C48345)
7 MM
Score: 1

NDC Code Structure

NDC 21130-784-29

Package Description: 3 BLISTER PACK in 1 CARTON > 5 TABLET in 1 BLISTER PACK

NDC 21130-784-30

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET in 1 BOTTLE

NDC Product Information

Allergy Relief with NDC 21130-784 is a a human over the counter drug product labeled by Safeway Inc. The generic name of Allergy Relief is fexofenadine hydrochloride. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 997420.

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

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 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.

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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)

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: Safeway Inc
Labeler Code: 21130
FDA Application Number: ANDA076502 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: 04-22-2013 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients


Fexofenadine is pronounced as (fex oh fen' a deen)

Why is fexofenadine medication prescribed?
Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching...
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Allergy Relief 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(S)

Fexofenadine HCl USP, 180 mg




  • Allergytemporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:runny nose itchy, watery eyessneezingitching of the nose or throatHivesreduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction  from occuring.


  • HivesSevere Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom: trouble swallowing   dizziness or loss of consciousness  swelling of tongue   swelling in or around mouth  trouble speaking  drooling  wheezing or problems breathing  These symptoms may be signs of anaphylactic shock. This condition canbe life threatening if not treated by a health professional immediately.Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later.Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times.

Do Not Use

  • Allergyif you have ever had an allergic reaction to this product or any of its ingredients.Hivesto prevent hives from any known cause such as:  foods insect stings medicines latex or rubber glovesbecause this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • Allergykidney disease. Your doctorshould determine if you need a different dose. Hives kidney disease. Your doctor should determine if you need a different dose.hives that are an unusual color, look bruised or blistered hives that do not itch

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 Doctor If

  • Allergyan allergic reaction to this product occurs. Seek medical help right away.Hivesan allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of  overdose, get medical help or contact a Poison Control Center right away.


180 mgadults and children 12 years of age and over         take one 180 mg tablet with water once a day; do not take more than 1 tablet 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

Safety sealed: do not use if carton is opened or if individual blister units are torn or opened.


Store between 20° - 25°C (68° - 77°F)protect from excessive moisturethis product meets the requirements of USP Dissolution Test 2.

Inactive Ingredients

Colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.


Container Carton Label: 30 count

Blister Carton Label: 15 Count

Blister Carton Label: 15 count

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