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Zero Allergy

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Efficient Laboratories Inc
NDC Code: 58593-827

Drug Facts

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).

Active Ingredient (per tablet)                 Purpose


Cetririzine HCl 10 mg ....................................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

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

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.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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)



If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

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 sever symptoms
adults 65 years and over
ask a doctor
children 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Othe information

  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20 degrees to 25 degrees C (68 to 77 degrees F)

Inactive ingredients

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

Questions?

Call: 1-305-805-3456 M-F 9:00AM - 5:00PM EST

ZERO ALLERGY 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-827
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
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:58593-827-1414 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749804/01/2013
Labeler - Efficient Laboratories Inc (969044932)

Revised: 03/2013
 
Efficient Laboratories Inc

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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