Cetirizine Hydrochloride

SPL v1

SPL

SPL Set ID 97802669-b4bd-4807-b3c1-6c6f5a2b0c67

Route

ORAL

Published

Effective Date 2022-07-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Acesulfame Potassium Silicon Dioxide Sucrose Crospovidone (120 .mu.m) Fd&c Blue No. 2 Fd&c Red No. 40 Guar Gum Magnesium Oxide Magnesium Stearate Mannitol Microcrystalline Cellulose Starch, Corn Talc

Identifiers & Packaging

Pill Appearance

Imprint: 344 Shape: round Color: purple Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2022-07-21

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

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.

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.

Section 50570-1

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.

Directions

may be taken with or without water
chew or crush tablets completely before swallowing

adults and children 6 years and over	Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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

Questions?

Call toll free 1-800-818-4555 weekdays

Other Information

store between 20° to 25°C (68° to 77°F)
do not use if inner safety seal is open or torn
see side panel for lot number and expiration date

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

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

If Pregnant Or Breast Feeding

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

Active Ingredient (in Each Chewable Tablet)

Cetirizine hydrochloride, USP 10 mg

Principal Display Panel 10 Mg Tablet Bottle Carton

^†Compare To

the active ingredient of

Children's Zyrtec^®

NDC 51660-066-30

ohm^®

Original Prescription Strength

Cetirizine

Hydrochloride

Chewable

Tablets 10 mg

Antihistamine

Allergy

Tutti-frutti Flavor

No Water Needed

Indoor + Outdoor Allergies

Actual Size

24 Hour Relief of:

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose

30 CHEWABLE

TABLETS

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

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.

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.

Section 50570-1 (50570-1)

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.

Purpose

Antihistamine

Directions

may be taken with or without water
chew or crush tablets completely before swallowing

adults and children 6 years and over	Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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

Questions?

Call toll free 1-800-818-4555 weekdays

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)
do not use if inner safety seal is open or torn
see side panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

When Using This Product (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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

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

Cetirizine hydrochloride, USP 10 mg

Principal Display Panel 10 Mg Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton)

^†Compare To

the active ingredient of

Children's Zyrtec^®

NDC 51660-066-30

ohm^®

Original Prescription Strength

Cetirizine

Hydrochloride

Chewable

Tablets 10 mg

Antihistamine

Allergy

Tutti-frutti Flavor

No Water Needed

Indoor + Outdoor Allergies

Actual Size

24 Hour Relief of:

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose

30 CHEWABLE

TABLETS

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (120 .MU.M)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAR GUM", "unii": "E89I1637KE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM OXIDE", "unii": "3A3U0GI71G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat", "42229-5": "Drug Facts", "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)", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "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.", "Purpose": "Antihistamine", "Directions": "may be taken with or without water chew or crush tablets completely before swallowing adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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", "Questions?": "Call toll free 1-800-818-4555 weekdays", "Other information": "store between 20° to 25°C (68° to 77°F) do not use if inner safety seal is open or torn see side panel for lot number and expiration date", "Inactive ingredients": "acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor", "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", "If pregnant or breast-feeding": "if breast-feeding: not recommended if pregnant: ask a health professional before use.", "Active ingredient (in each chewable tablet)": "Cetirizine hydrochloride, USP 10 mg", "PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton": "† Compare To the active ingredient of Children's Zyrtec ® NDC 51660-066-30 ohm ® Original Prescription Strength Cetirizine Hydrochloride Chewable Tablets 10 mg Antihistamine Allergy Tutti-frutti Flavor No Water Needed Indoor + Outdoor Allergies Actual Size 24 Hour Relief of: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose 30 CHEWABLE TABLETS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:16.798735 · Updated: 2026-03-14T23:00:39.941399