Cetirizine Hydrochloride Tablets Usp 10 Mg

Cetirizine Hydrochloride Tablets Usp 10 Mg
SPL v1
SPL
SPL Set ID 9af4ab23-d6d3-43f9-a026-76fd9771963f
Route
ORAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: CTN;10 Shape: bullet Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2025-03-04
Description

Active Ingredient (in each tablet) Cetirizine HCl USP 10 mg

Medication Information

Description

Active Ingredient (in each tablet) Cetirizine HCl USP 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
Pupose

Antihistamine

Section 42229-5

Manufactured by:

Unique Pharmaceutical Laboratories

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Distributed by:

Umasuto, LLC

14130 Minnesota Avenue, Bonner Springs,

KS 66012

Issued 03/2025

Section 50566-9

Stop use and ask a doctorif an allergic reaction to this product occurs. Seek medical help right away.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 55106-9

Active Ingredient (in each tablet)

Cetirizine HCl USP 10 mg

Warnings

Do Not Useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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 sever 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 1-866-768-0551

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)

Principal Display Panel 100's Count

UMASUTO NDC 85293-001-01

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg

Compare to the active ingredient in Zyrtec

Antihistamine

ALLERGY

Indoor & Outdoor Allergies

24 Hour Relief of:

•Sneezing

•Runny Nose

•Itchy, Watery Eyes

•Itchy Throat or Nose

6 yrs& older 100 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
Pupose

Antihistamine

Section 42229-5 (42229-5)

Manufactured by:

Unique Pharmaceutical Laboratories

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Distributed by:

Umasuto, LLC

14130 Minnesota Avenue, Bonner Springs,

KS 66012

Issued 03/2025

Section 50566-9 (50566-9)

Stop use and ask a doctorif 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 aretaking tranquilizers or sedatives.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 55106-9 (55106-9)

Active Ingredient (in each tablet)

Cetirizine HCl USP 10 mg

Warnings

Do Not Useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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 sever 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 1-866-768-0551

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 (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)

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

UMASUTO NDC 85293-001-01

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg

Compare to the active ingredient in Zyrtec

Antihistamine

ALLERGY

Indoor & Outdoor Allergies

24 Hour Relief of:

•Sneezing

•Runny Nose

•Itchy, Watery Eyes

•Itchy Throat or Nose

6 yrs& older 100 Tablets

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:42.456833 · Updated: 2026-03-14T23:07:53.934759