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Cetirizine Hydrochloride by Proficient Rx LP

Medically reviewed on June 6, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Proficient Rx LP
NDC Code: 63187-110

Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Cetirizine HCl, 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

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
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.(for bottle cartons/stand-alone labels only)
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.(for blister cartons only)
store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENTS

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Zyrtec®

NDC 51660-939-54

ohm®

Original Prescription Strength

Cetirizine HCl Tablets, 10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

14 TABLETS 10 mg EACH

This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec®. Zyrtec® is a registered trademark of UCB Pharma, S.A.

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-110(NDC:51660-939)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (rounded-off) Size9mm
FlavorImprint CodeRI52
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-110-3030 TABLET in 1 BOTTLE
2NDC:63187-110-9090 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749812/27/2007
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022RELABEL(63187-110), REPACK(63187-110)

 
Proficient Rx LP

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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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