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NDC 68788-7585-01 Cetirizine Hydrochloride 5 mg/5mL Details
Cetirizine Hydrochloride 5 mg/5mL
Cetirizine Hydrochloride is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is CETIRIZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 68788-7585-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 68788-7585 |
|---|---|
| Product ID | 68788-7585_2b0cf72a-d569-47b5-9b5d-f84177bc6c7f |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Cetirizine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Preferred Pharmaceuticals Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091130 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 68788-7585-01 (68788758501)
| NDC Package Code | 68788-7585-1 |
|---|---|
| Billing NDC | 68788758501 |
| Package | 120 mL in 1 CARTON (68788-7585-1) |
| Marketing Start Date | 2020-02-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 90aba37b-89cd-412b-80ff-2a6d893e41a6 Details
Drug Facts
Uses
Warnings
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
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
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
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help 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 doctor |
Other information
Store between 20º to 25ºC (68º to 77ºF)
Inactive ingredients
Drug Facts
Uses
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 breathing
These 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.
Do not use
- •
- 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
- •
- hives that are an unusual color, look bruised or blistered
- •
- hives that do not itch
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
Stop use and ask a doctor if
- •
- 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
Directions
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 doctor |
Other information
Store between 20º to 25ºC (68º to 77ºF)
Inactive ingredients
SPL UNCLASSIFIED SECTION
Dosing Cup Included
Dosing 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 INFORMATION
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-7585-1
INGREDIENTS AND APPEARANCE
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride solution |
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| Labeler - Preferred Pharmaceuticals Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 791119022 | RELABEL(68788-7585) | |