CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Rising Pharma Holdings, Inc.

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Cetirizine Hydrochloride Tablets USP
5 mg, Allergy

ACTIVE INGREDIENTS (IN EACH TABLET)

Cetirizine HCl USP 5 mg

PURPOSE

Antihistimine

USES

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

WARNINGS:

DO NOT USE

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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING THIS PRODUCT

  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

STOP USE

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 Poison Control Center right away. (1-800-222-1222)

DIRECTIONS


Adults and children 6years and over

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

Adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

Children under 6 years of age

Ask a doctor

Consumers with liver or kidney disease

Ask a doctor



OTHER INFORMATION

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

INACTIVE INGREDIENTS

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

QUESTIONS

Call 1-844-874-7464

Manufactured by:

Unique Pharmaceutical Labs,

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India.

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

M.L. G/1430     July 2020

129575


Cetirizine Hydrochloride Tablets USP 5 mg

Rising NDC 16571-401-10

Original Prescription Strength

Cetirizine Hydrochloride
Tablets 5 mg

100 Tablets

cetrizine-50mg-1

cetrizine-50mg-2

cetrizine-50mg-3

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
lactose (UNII: J2B2A4N98G)  
magnesium stearate (UNII: 70097M6I30)  
starch, corn (UNII: O8232NY3SJ)  
polyethylene glycol (UNII: 3WJQ0SDW1A)  
povidone (UNII: FZ989GH94E)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint Code CTN;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-401-10100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Rising Pharma Holdings, Inc. (835513529)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645ANALYSIS(16571-401) , MANUFACTURE(16571-401)

Revised: 11/2021
Document Id: 65ec42df-09a8-418a-b663-029a0733bdb7
Set id: 6493d4f6-dead-45ec-ade1-28ce624af33d
Version: 6
Effective Time: 20211102
 
Rising Pharma Holdings, Inc.