Zyrtec Hives

Zyrtec Hives
SPL v2
SPL
SPL Set ID 31136e3a-94fa-0860-e063-6394a90a008d
Route
ORAL
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Hypromelloses Lactose Monohydrate Silicon Dioxide Magnesium Stearate Microcrystalline Cellulose Croscarmellose Sodium Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ZYRTEC;10mg Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
NDA Active Since 2025-06-02

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50566-9

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
Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3

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
Section 51945-4

Original Prescription Strength

NDC 50580-116-30

ZYRTEC ® HIVES

Cetirizine HCl tablets

10mg/antihistamine

Hives Relief

24 Hour relief

Reduces Hives

Reduces Itching Due to Hives

30 Tablets 10 mg each

Actual Size

30 TABLETS

Section 53413-1

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).

Section 53414-9

If pregnant or breast-feeding:

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

6 years and over
one 10 mg tablet once daily; do not take

more than one 10 mg tablet in 24 hours.

A 5 mg product may be appropriate for

less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years

of age
ask a doctor
consumers with liver or

kidney disease
ask a doctor

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.
Other Information

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing
  • meets USP Dissolution Test 2
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium,hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Severe Allergy Warning

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 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 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.

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 mg


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

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
Section 51945-4 (51945-4)

Original Prescription Strength

NDC 50580-116-30

ZYRTEC ® HIVES

Cetirizine HCl tablets

10mg/antihistamine

Hives Relief

24 Hour relief

Reduces Hives

Reduces Itching Due to Hives

30 Tablets 10 mg each

Actual Size

30 TABLETS

Section 53413-1 (53413-1)

Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

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

Antihistamine

Directions
adults and children

6 years and over
one 10 mg tablet once daily; do not take

more than one 10 mg tablet in 24 hours.

A 5 mg product may be appropriate for

less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years

of age
ask a doctor
consumers with liver or

kidney disease
ask a doctor

Do Not Use (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.
Other Information (Other information)

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing
  • meets USP Dissolution Test 2
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium,hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Severe Allergy Warning

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 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 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Cetirizine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

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