CETIRIZINE HYDROCHLORIDE tablet

CETIRIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

CETIRIZINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Apotheca Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

(in each Tablet)
Cetirizine HCI 10mg

PURPOSE

ANTIHISTAMINE
24 Hour Relief of Indoor and Outdoor Allergies

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

• 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 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.

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.
• 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 and inactive ingredients

Other information

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

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions

Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL

NDC: 12634-987-71
CETIRIZINE HCI
Antihistamine
Indoor and Outdoor Allergies
24 Hour Relief of Sneezing, Runny Nose, Itchy,
Watery Eyes, Itchy Throat or Nose.
Allergy Tablets
RejuviLife
30 Tablets
10 MG

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12634-987(NDC:0378-3637)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	8mm
Flavor		Imprint Code	M;C37
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12634-987-96	6 in 1 BOTTLE, PLASTIC
2	NDC: 12634-987-97	7 in 1 BOTTLE, PLASTIC
3	NDC: 12634-987-00	10 in 1 BOTTLE, PLASTIC
4	NDC: 12634-987-80	20 in 1 BOTTLE, PLASTIC
5	NDC: 12634-987-71	30 in 1 BOTTLE, PLASTIC
6	NDC: 12634-987-50	50 in 1 BOTTLE, PLASTIC
7	NDC: 12634-987-01	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076677	01/01/2010

Labeler - Apotheca Inc. (051457844)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Inc.		051457844	repack, relabel