NDC 68788-7585 Cetirizine Hydrochloride

Cetirizine Hydrochloride

NDC Product Code 68788-7585

NDC 68788-7585-1

Package Description: 120 mL in 1 CARTON

NDC Product Information

Cetirizine Hydrochloride with NDC 68788-7585 is a a human over the counter drug product labeled by Preferred Pharmaceuticals Inc.. The generic name of Cetirizine Hydrochloride is cetirizine hydrochloride. The product's dosage form is solution and is administered via oral form.

Labeler Name: Preferred Pharmaceuticals Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Cetirizine 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.

  • CETIRIZINE HYDROCHLORIDE 5 mg/5mL

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.

  • CALCIUM ACETATE (UNII: Y882YXF34X)
  • ACETIC ACID (UNII: Q40Q9N063P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)

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: Preferred Pharmaceuticals Inc.
Labeler Code: 68788
FDA Application Number: ANDA091130 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: 02-18-2020 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: 12-31-2021 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 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.

Cetirizine 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

Drug Facts

Active ingredient (in each 5 mL (teaspoonful(tsp)): Cetirizine HCl 5 mg

Active ingredient (in each 5 mL (teaspoonful)): Cetirizine HCl 5 mg

Otc - Purpose

Purpose: Antihistamine

Purpose: Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

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

  • •to prevent hives from any known cause such as: •foods •insect stings •medicines •latex or rubber gloves because 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 or to an antihistamine containing hydroxyzine.

Ask A Doctor Before Use If You Have

Liver or kidney disease. Your doctor should determine if you need a different dose.

  • •liver or 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

Ask A Doctor Or Pharmacist Before Use If You Are

Taking tranquilizers or sedatives.

Taking tranquilizers or sedatives

When Using This Product

  • • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery

  • •drowsiness may occur •avoid alcoholic drinks •alcohol, sedatives, and tranquilizers may increase drowsiness •be 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.

  • •an 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

  • •If breast-feeding: not recommended •if pregnant: ask a health professional before use.

  • •If breast-feeding: not recommended •if 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.(1-800-222-1222)

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

Directions

Use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (tsp)(5 mL) or 2 teaspoonfuls (tsp)(10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (tsp)(10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (tsp)(5 mL) once daily; do not take more than 1 teaspoonful (tsp)(5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (tsp)(2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (tsp)(5 mL) once daily or 1/2 teaspoonful (tsp)(2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (tsp)(5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctorOther information  Store between 20º to 25ºC (68º to 77ºF)

Use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctorOther informationStore between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

Calcium acetate, grape flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water.

Calcium acetate, grape flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water

Questions?

Call 1-888-974-5279

Call 1-888-974-5279

Warnings

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

Other

Dosing Cup IncludedDosing cup should be washed and left to air dry after each use.Do not use if carton is open; or if safety seal printed with “SEALED FOR YOUR PROTECTION” around cap of the bottle is broken or missing.SAVE THIS CARTON FOR FULL LABELING INFORMATIONRelabeled By: Preferred Pharmaceuticals Inc.NDC 68788-7585-1

* Please review the disclaimer below.