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

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Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

Active Ingredient (in each tablet)                                                

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 tothis 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 tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
Adults 65 years and overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk 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    Jul. 2020

126406

PRINCIPAL DISPLAY PANEL-100'S COUNT

Rising® 16571-402-10

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older

Antihistamine
ALLERGY
Indoor & Outdoor Allergies
24 Hour Relief of:
•Sneezing
•Runny Nose
•Itchy, Watery Eyes
•Itchy Throat or Nose


100 Tablets

T10 - M.L. G/1430
Cetrizine-10mg-100ct-1
cetrizine-10mg-100ct-2
cetrizine-10mg-100ct-3

T20 - M.L. G/25/2188

Cetrizine-10mg-100ct-4

Cetrizine-10mg-100ct-5

Cetrizine-10mg-100ct-6

PRINCIPAL DISPLAY PANEL-500'S COUNT

Rising® 16571-402-50

Original Prescription Strength

Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older

Antihistamine
ALLERGY
Indoor & Outdoor Allergies
24 Hour Relief of:
•Sneezing
•Runny Nose
•Itchy, Watery Eyes
•Itchy Throat or Nose

500 Tablets

T10 - M.L. G/1430

Cetrizine-10mg-500ct-1

cetrizine-10mg-500ct-2

cetrizine-10mg-500ct-3

T20 - M.L. G/25/2188

Cetrizine-10mg-500ct-4

Cetrizine-10mg-500ct-5

Cetrizine-10mg-500ct-6

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-402
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
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) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-402-10100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
2NDC:16571-402-50500 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. (116880195)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645MANUFACTURE(16571-402) , analysis(16571-402)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories864354608analysis(16571-402) , manufacture(16571-402)

Revised: 2/2024
Document Id: 76ebe5e7-afda-45c3-bf06-07e37827a07a
Set id: 5481ccb3-b311-4b25-b923-4fe8522ea92b
Version: 12
Effective Time: 20240222
 
Rising Pharma Holdings, Inc.