CETIRIZINE HYDROCHLORIDE tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Rising Pharmaceuticals, Inc., Unique Pharmaceutical Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active Ingredients (in each tablet)                                                Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

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 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 tothis 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.

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 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° 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 1-866-562-4597

SPL UNCLASSIFIED SECTION

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Distributed by:

Rising Pharmaceuticals, Inc.
Saddle Brook, NJ 07663

 

M. L. G/1430    May 2018

 

120005

PRINCIPAL DISPLAY PANEL-100'S COUNT

———PRINCIPAL DISPLAY PANEL———
Rising® 16571-402-10
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older
100 Tablets

PRINCIPAL DISPLAY PANEL-500'S COUNT

———PRINCIPAL DISPLAY PANEL———
Rising® 16571-402-50
Original Prescription Strength
Cetirizine Hydrochloride Tablets USP 10 mg
6 yrs & older
500 Tablets

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16571-402
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
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
Color	WHITE (White)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	8mm
Flavor		Imprint Code	CTN;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16571-402-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009
2	NDC: 16571-402-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077829	10/01/2009

Labeler - Rising Pharmaceuticals, Inc. (835513529)

Registrant - Unique Pharmaceutical Laboratories (917165052)

Establishment
Name	Address	ID/FEI	Business Operations
Unique Pharmaceutical Laboratories		650434645	MANUFACTURE(16571-402)