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Cetirizine Hydrochloride by FAMILY DOLLAR SERVICES, INC

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: FAMILY DOLLAR SERVICES, INC
NDC Code: 55319-939

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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

OTHER INFORMATION
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • 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

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

COMPARE TO THE ACTIVE INGREDIENT OF ZYRTEC®*

NDC 55319-939-54

FAMILY
wellness™

100% SATISFACTION
OR YOUR MONEY BACK
GUARANTEED

Allergy Relief
Cetirizine HCl Tablets, USP 10 mg/Antihistamine

Indoor & Outdoor Allergies

Relief of:

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

24
HOUR

Original Prescription Strength

14 TABLETS 10 mg EACH

ACTUAL SIZE

OTC
network

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-939
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (Rounded Off) Size9mm
FlavorImprint CodeR152
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-939-3030 TABLET in 1 BOTTLE
2NDC:55319-939-5414 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749809/01/2017
Labeler - FAMILY DOLLAR SERVICES, INC (024472631)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029manufacture(55319-939)

Revised: 01/2018
 
FAMILY DOLLAR SERVICES, 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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