Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID a042d98d-35ad-4d40-8b27-79dafd028096
Route
ORAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: IP;46 Shape: oval Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Completed Since 2010-09-01 Until 2026-09-01
Description

Cetirizine HCl 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 10 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
Directions
adults and children 6 years and over  Take 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

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Package Labeling
READYinCASE All Day Allergy Relief
Other Information
  • store between 20º to 25ºC (68º to 77ºF)
Inactive Ingredients

lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol,  povidone, starch, talc,  titanium dioxide

Questions Or Comments?

Call  1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Zyrtec®†

all day

allergy relief

cetirizine HCl tablets 10 mg

antihistamine

24 hour relief of:

  • sneezing
  • itchy, watery eyes
  • runny nose
  • itchy throat or nose

tablets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

When Using This Product
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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.

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 a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

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
Purpose

Antihistamine

Directions
adults and children 6 years and over  Take 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)

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Package Labeling
READYinCASE All Day Allergy Relief
Other Information
  • store between 20º to 25ºC (68º to 77ºF)
Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol,  povidone, starch, talc,  titanium dioxide

Questions Or Comments? (Questions or comments?)

Call  1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Zyrtec®†

all day

allergy relief

cetirizine HCl tablets 10 mg

antihistamine

24 hour relief of:

  • sneezing
  • itchy, watery eyes
  • runny nose
  • itchy throat or nose

tablets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

When Using This Product (When using this product)
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

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 a Poison Control Center right away.

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

Cetirizine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:48.737883 · Updated: 2026-03-14T23:09:46.965889