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Cetirizine Hydrochloride by Preferred Pharmaceuticals, Inc.

Medically reviewed on April 18, 2018

Dosage form: tablet
Ingredients: Cetirizine Hydrochloride 10mg
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-0790

Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

Active Ingredients

Active Ingredients (in each tablet)                                                Purpose

Cetirizine HCl USP 10 mg................................................................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 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
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 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.

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 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 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 for:

Rising Pharmaceuticals, Inc.
Allendale, NJ 07401

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

M.L G/1430    Nov. 2016

120005

Repackaged By: Preferred Pharmaceuticals Inc.

———PRINCIPAL DISPLAY PANEL———
Rising® 68788-0790
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0790(NDC:16571-402)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED 
LACTOSE, UNSPECIFIED FORM 
magnesium stearate 
starch, corn 
POVIDONE, UNSPECIFIED 
titanium dioxide 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint CodeCTN;10
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-0790-114 TABLET in 1 BOTTLE
2NDC:68788-0790-515 TABLET in 1 BOTTLE
3NDC:68788-0790-330 TABLET in 1 BOTTLE
4NDC:68788-0790-660 TABLET in 1 BOTTLE
5NDC:68788-0790-990 TABLET in 1 BOTTLE
6NDC:68788-0790-0100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-0790)

 
Preferred Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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