Cetirizine Hydrochloride Tablets Usp

SPL v7

SPL

SPL Set ID 6493d4f6-dead-45ec-ade1-28ce624af33d

Route

ORAL

Published

Effective Date 2024-02-22

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg)

Inactive Ingredients

Hypromelloses Lactose Magnesium Stearate Starch, Corn Polyethylene Glycol Povidone Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: CTN;5 Shape: bullet Color: white Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2009-10-01

Description

Cetirizine HCl USP 5 mg

Purpose

Antihistimine

Medication Information

Purpose

Antihistimine

Description

Cetirizine HCl USP 5 mg

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

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.

Section 51945-4

T20 - M.L. G/25/2188

Directions

Adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
Adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Questions?

Call 1-844-874-7464

Other Information:

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

When Using This Product

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

If Pregnant Or Breast Feeding:

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

Keep Out of Reach of Children.

In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)

Active Ingredient (in Each Tablet)

Cetirizine HCl USP 5 mg

Principal Display Panel 100's Count

Rising NDC 16571-401-10

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 5 mg

Antihistamine

ALLERGY

Indoor & Outdoor Allergies

24 Hour Relief of:

•Sneezing

•Runny Nose

•Itchy, Watery Eyes

•Itchy Throat or Nose

100 Tablets

T10 - M.L. G/1430

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)

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.

Section 51945-4 (51945-4)

T20 - M.L. G/25/2188

Purpose

Antihistimine

Directions

Adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
Adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Questions?

Call 1-844-874-7464

Other Information: (Other information:)

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

When Using This Product (When using this product)

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

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

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

Keep Out of Reach of Children. (keep out of reach of children.)

In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)

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

Cetirizine HCl USP 5 mg

Principal Display Panel 100's Count (PRINCIPAL DISPLAY PANEL-100'S COUNT)

Rising NDC 16571-401-10

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 5 mg

Antihistamine

ALLERGY

Indoor & Outdoor Allergies

24 Hour Relief of:

•Sneezing

•Runny Nose

•Itchy, Watery Eyes

•Itchy Throat or Nose

100 Tablets

T10 - M.L. G/1430

Advanced Ingredient Data

[{"name": "Cetirizine", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "lactose", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "starch, corn", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "polyethylene glycol", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "povidone", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "titanium dioxide", "unii": "15FIX9V2JP", "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": "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.", "51945-4": "T20 - M.L. G/25/2188", "Purpose": "Antihistimine", "Directions": "Adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours Adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor", "Questions?": "Call 1-844-874-7464", "Other information:": "Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].", "Inactive ingredients": "hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.", "When using this product": "drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary.", "If pregnant or breast-feeding:": "if breast-feeding: not recommended if pregnant: ask a health professional before use.", "keep out of reach of children.": "In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)", "Active Ingredient (in each tablet)": "Cetirizine HCl USP 5 mg", "PRINCIPAL DISPLAY PANEL-100'S COUNT": "Rising NDC 16571-401-10 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose 100 Tablets T10 - M.L. G/1430"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:52.801255 · Updated: 2026-03-14T23:02:40.652524