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Cetirizine Hydrochloride by Strides Pharma Inc

Medically reviewed on July 28, 2017

Dosage form: capsule, liquid filled
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Strides Pharma Inc
NDC Code: 59556-769

DRUG FACTS

Active ingredient (in each capsule)

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

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 capsule once daily; do not take more than one 10 mg capsule 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°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if tamper-evident seal under cap imprinted with "Sealed for your Protection" is broken or missing.

Inactive ingredients

gelatin, medium chain triglyceride, polyethylene glycol 400, printing ink white (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide) purified water, sodium hydroxide, sorbitol-sorbitan solution.

Questions or comments?

call 1-877-244-9825

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container label

Carton label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-769
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
ISOPROPYL ALCOHOL 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorYELLOW (colorless to pale yellow) Scoreno score
ShapeOVALSize14mm
FlavorImprint Code291
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-769-121 BOTTLE in 1 CARTON
140 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20529107/21/2017
Labeler - Strides Pharma Inc (078868278)
Registrant - Strides Shasun Limited (650738743)
Establishment
NameAddressID/FEIOperations
Strides Shasun Limited918513263ANALYSIS(59556-769), MANUFACTURE(59556-769), PACK(59556-769)

 
Strides Pharma Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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