DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

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:

• 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 andover: 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 kidneydisease: 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-769
Route of Administration	ORAL

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
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
Color	YELLOW (colorless to pale yellow)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	291
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-769-12	1 in 1 CARTON	07/21/2017	07/19/2019
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA205291	07/21/2017	07/19/2019

Labeler - Strides Pharma Inc (078868278)

Registrant - Strides Pharma Science Limited (650738743)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		918513263	ANALYSIS(59556-769) , MANUFACTURE(59556-769) , PACK(59556-769)

Revised: 1/2019

Document Id: ea1497a2-7c98-4616-8900-3b15fcc18910

34390-5

Set id: 0b8814c0-b053-43e9-8234-22600758a59d

Version: 3

Effective Time: 20190103