ALL DAY ALLERGY RELIEF 24 HOUR- cetirizine hydrochloride tablet 
McKesson (Sunmark)

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DRUG FACTS

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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.

Directions

adults and children 6 years and over Take 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

Inactive ingredients

lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, and titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ZYRTEC® ACTIVE INGREDIENT*

24 hour

all day allergy

Original Prescription Strength

Cetirizine HCl Tablets, 10 mg

Antihistamine

Indoor & outdoor allergies

24 hour relief of

runny nose, sneezing,

itchy, watery eyes,

itching of the nose or throat

GLUTEN FREE

ALLERGY TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Zyrtec®.

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Another Quality Product Distributed By McKesson

One Post Street, San Francisco, CA 94104

Please visit us at www.sunmarkbrand.com

Product Label

Cetirizine HCl 10 mg

Sunmark All Day Allergery Tablet

ALL DAY ALLERGY RELIEF  24 HOUR
cetirizine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-984
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code IP46
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-984-46 1 in 1 CARTON
1 14 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078780 03/15/2013
Labeler - McKesson (Sunmark) (177667227)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
Document Id: 05657d14-ba53-4412-b69f-382a32de3f47
Set id: 9f60e43e-a05a-4158-852e-aa96b8199d2f
Version: 3
Effective Time: 20130422
 
McKesson (Sunmark)