CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride capsule, liquid filled 
Strides Pharma Inc

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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:

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

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

If pregnant or breast-feeding:

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

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

carton label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-894
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (colorless to pale yellow) Scoreno score
ShapeOVALSize14mm
FlavorImprint Code 291
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-894-121 in 1 CARTON07/21/2017
140 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59556-894-771 in 1 CARTON05/21/2018
212 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59556-894-797000 in 1 BAG; Type 0: Not a Combination Product05/21/2018
4NDC:59556-894-781 in 1 CARTON05/21/2018
425 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20529107/21/2017
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Strides Pharma Science Limited918513263ANALYSIS(59556-894) , MANUFACTURE(59556-894) , PACK(59556-894)

Revised: 1/2023
Document Id: ecf83e2f-6c1b-40ec-8acb-3bd99051ea66
Set id: 29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba
Version: 2
Effective Time: 20230110
 
Strides Pharma Inc