Cetirizine Hydrochloride

Cetirizine Hydrochloride
SPL v2
SPL
SPL Set ID efd3921f-f450-44c4-aa9c-f5e53e0f86ec
Route
ORAL
Published
Effective Date 2019-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Povidone, Unspecified Lactose Monohydrate Magnesium Stearate Starch, Corn Talc Titanium Dioxide Hypromellose, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: RI52 Shape: rectangle Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2019-07-31
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 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.

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.

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
Questions?

call 1-844-428-2538

Other Information
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F)
Inactive Ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Active Ingredient (in Each Tablet)

Cetirizine HCl, USP 10 mg

Principal Display Panel 10 Mg Tablet Blister Pack Carton

24/7 life

BY 7-ELEVEN™

Original Prescription Strength

Allergy Relief

Cetirizine Hydrochloride Tablets,

USP 10 mg

Antihistimine

Indoor & Outdoor Allergies

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy throat or nose

compare to the

Zyrtec®

active ingredient*

14

TABLETS

10 mg EACH

Actual Size

• QUALITY •

GUARANTEED

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 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.

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.

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
Questions?

call 1-844-428-2538

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F)
Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

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

Cetirizine HCl, USP 10 mg

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

24/7 life

BY 7-ELEVEN™

Original Prescription Strength

Allergy Relief

Cetirizine Hydrochloride Tablets,

USP 10 mg

Antihistimine

Indoor & Outdoor Allergies

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy throat or nose

compare to the

Zyrtec®

active ingredient*

14

TABLETS

10 mg EACH

Actual Size

• QUALITY •

GUARANTEED

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:51.027051 · Updated: 2026-03-14T22:55:36.629297