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Cetirizine Hydrochloride by Rising Pharmaceuticals, Inc.

Dosage form: tablet
Ingredients: Cetirizine Hydrochloride 5mg
Labeler: Rising Pharmaceuticals, Inc.
NDC Code: 16571-401

Cetirizine Hydrochloride Tablets USP
5 mg, Allergy

ACTIVE INGREDIENTS (IN EACH TABLET)

Cetirizine HCl USP 5 mg

PURPOSE

Antihistimine

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

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 DOCTOR

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

ASK DOCTOR/PHARMACIST

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

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.

STOP USE

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 Poison Control Center right away. (1-800-222-1222)

DIRECTIONS

Adults and children 6years and over

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

Adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

Children under 6 years of age

Ask a doctor

Consumers with liver or kidney disease

Ask a doctor



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.

QUESTIONS

Call 1-866-562-4597

Manufactured by:

Unique Pharmaceutical Labs,

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

Mumbai 400 030, India.

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

M. L. G/1430      May 2018

120004


Cetirizine Hydrochloride Tablets USP 5 mg

Rising NDC 16571-401-10

Original Prescription Strength

Cetirizine Hydrochloride
Tablets 5 mg

100 Tablets





CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-401
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
lactose 
magnesium stearate 
starch, corn 
polyethylene glycol 
povidone 
titanium dioxide 
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint CodeCTN;5
Contains    
Packaging
#Item CodePackage Description
1NDC:16571-401-10100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Rising Pharmaceuticals, Inc. (835513529)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIOperations
Unique Pharmaceutical Laboratories650434645ANALYSIS(16571-401), MANUFACTURE(16571-401)

 
Rising Pharmaceuticals, Inc.

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Medically reviewed on May 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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