OTC Medication Information: Cetirizine Hydrochloride (Allergy)

CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet
BluePoint Laboratories

Drug Facts

Active ingredient (in each tablet)


For 10 mg: 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

For 10 mg:

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

Other information

  • store between 20° to 25°C (68° to 77°F)
  • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

call 1-855-274-4122
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India
For BluePoint Laboratories
Made in India Code: TS/DRUGS/19/1993

Issued 05/2020

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30’s Tablet Container Carton Label)

Cetirizine fig.1
(click image for full-size original)

NDC 68001-436-04
*Compare to the active
ingredient of Zyrtec ®
Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
24 Hour Relief of :

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

30 Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (10 x 10 Blister Carton Label)

Cetirizine fig.2
(click image for full-size original)

NDC68001436-96
*Compare to the active
ingredient of Zyrtec ®
Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
24 Hour Relief of :

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

100 (10×10) Tablets
10 mg each

CETIRIZINE HYDROCHLORIDE (ALLERGY) cetirizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68001-436
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code X;36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-436-96 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68001-436-96)
2 NDC:68001-436-04 1 BOTTLE in 1 CARTON contains a BOTTLE
2 30 TABLET in 1 BOTTLE This package is contained within the CARTON (68001-436-04)
3 NDC:68001-436-97 1 BOTTLE in 1 CARTON contains a BOTTLE
3 300 TABLET in 1 BOTTLE This package is contained within the CARTON (68001-436-97)
4 NDC:68001-436-16 10 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090760 06/19/2020
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 analysis (68001-436), manufacture (68001-436)

Revised: 07/2021 BluePoint Laboratories

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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