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
Cetirizine Hydrochloride
FDA Label NDC 50090-4379
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Cetirizine Hydrochloride (NDC 50090-4379). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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 20° to 25°C (68° to 77°F)
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 20° to 25°C (68° to 77°F)
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
Cetirizine Hydrochloride Oral Solution - Hives Relief
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.
* Please review the disclaimer below.
