CETIRIZINE HYDROCHLORIDE tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)                                                        Purpose

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

OTC - PURPOSE SECTION

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 SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

INSTRUCTIONS FOR USE SECTION

• 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 sever 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

DOSAGE & ADMINISTRATION SECTION

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 sever 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 SAFETY INFORMATION

store between 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

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

​OTC - QUESTIONS SECTION

Call 1-866-562-4597

SPL UNCLASSIFIED SECTION

Manufactured for PACK Pharmaceuticals, LLC

Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-538(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 GLYCOLS (UNII: 3WJQ0SDW1A)
povidone (UNII: FZ989GH94E)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	BULLET	Size	8mm
Flavor		Imprint Code	CTN;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-538-30	30 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	ANDA077829	01/01/2014

Labeler - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	relabel(61919-538) , repack(61919-538)