Cetirizine Hydrochloride Oral Solution

Cetirizine Hydrochloride Oral Solution
SPL v11
SPL
SPL Set ID 7d16ccca-6aa3-4575-9fa7-f57301801a81
Route
ORAL
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg)
Inactive Ingredients
Acetic Acid Glycerin Methylparaben Propylene Glycol Propylparaben Sodium Acetate Sucrose Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2009-10-07

Description

*Compared to Children’s Zyrtec ® active ingredient Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

*Compared to Children’s Zyrtec ® active ingredient Drug Facts

Uses

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

Section 42229-5

*Compared to Children’s Zyrtec® active ingredient

Drug Facts

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • swelling of tongue
  • trouble speaking
  • wheezing or problems breathing
  • dizziness or loss of consciousness
  • swelling in or around the mouth
  • drooling

The symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a 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 injection 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

Ask a doctor or pharmacist before use if you are 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

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

If pregnant or breastfeeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Directions
  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter
 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 56 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
Questions?

Call 1-877-835-5472

Monday through Friday 9AM – 5PM EST.

Active Ingredient

(in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.
Inactive Ingredients

Sucrose, Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sodium Acetate, Glacial Acetic Acid, Artificial Grape Flavor, Purified Water.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help of contact a Poison Control Center right away. (1-800-222-1222)

Package Label.principal Display Panel

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

*Compared to Children’s Zyrtec® active ingredient

Drug Facts

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • swelling of tongue
  • trouble speaking
  • wheezing or problems breathing
  • dizziness or loss of consciousness
  • swelling in or around the mouth
  • drooling

The symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a 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 injection 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

Ask a doctor or pharmacist before use if you are 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

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

If pregnant or breastfeeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Directions
  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter
 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 56 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
Questions?

Call 1-877-835-5472

Monday through Friday 9AM – 5PM EST.

Active Ingredient (ACTIVE INGREDIENT)

(in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • TAMPER EVIDENT: DO NOT USE IF NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.
Inactive Ingredients (INACTIVE INGREDIENTS)

Sucrose, Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sodium Acetate, Glacial Acetic Acid, Artificial Grape Flavor, Purified Water.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. In case of overdose, get medical help of contact a Poison Control Center right away. (1-800-222-1222)

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)