Cetirizine Hydrochloride: Package Insert and Label Information

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable
OHM LABORATORIES INC.

Drug Facts

Active ingredient (in each chewable tablet)

Cetirizine hydrochloride, USP 10 mg

Purpose

Antihistamine

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

Warnings

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.

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.

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

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. (1-800-222-1222)

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

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

Questions?

Call toll free 1-800-818-4555 weekdays

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

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

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Carton
(click image for full-size original)
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-066
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color PURPLE Score no score
Shape ROUND Size 10mm
Flavor TUTTI FRUTTI Imprint Code 344
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-066-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (51660-066-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090142 07/21/2022
Labeler — OHM LABORATORIES INC. (184769029)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 MANUFACTURE (51660-066)

Revised: 07/2022 OHM LABORATORIES INC.

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