ALLEROFF- cetirizine hydrochloride tablet

ALLEROFF by

Drug Labeling and Warnings

ALLEROFF by is a Otc medication manufactured, distributed, or labeled by Corporacion Infarmasa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cetirizine HCL 10 mg..........Antihistamine

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:

• Drowsiness may occur
• Avoid alcoholic drinks
• Alcohol, sedatives and tranquilizers may increase drowsiness
• Be careful when driving a motor vehicle or operating machinery

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 hidroxyzine

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)

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding:

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

STOP USE

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

PURPOSE

Uses

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

• Runny Nose
• Itchy,water eyes
• Itching of the nose or throat
• Sneezing

QUESTIONS

If you have questions of a medical nature, please contact your pharmacist, doctor or health care profesional

Questions or comments? 561 338 5221

STORAGE AND HANDLING

Do not use if blister unit is broken or lorn

Store between 20ºC to 25ºC ( 68ºF to 77ºF)

DOSAGE & ADMINISTRATION

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 strenght may be appropiate for less severe symptoms

Adults 65 years and over                               Ask a Doctor

Children under 6 years of age                         Ask a Doctor

Consumer with liver or kidney disease             Ask a Doctor

INACTIVE INGREDIENT

Microcrystalline Cellulose, Lactose Monohydrate, Crosscaramellose Sodium, Magnesium Stearate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLEROFF 
cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16853-1305
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10.0 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)	150.0 mg
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)	5.0 mg
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)	50.0 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	2.0 mg

Product Characteristics
Color	white (white)	Score	score with uneven pieces
Shape	ROUND (Tablet)	Size	8mm
Flavor		Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16853-1305-2	00000000000001 in 1 BOX
1	NDC: 16853-1305-1	000000000010 in 1 BLISTER PACK
2	NDC: 16853-1305-3	0000000002 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019835	01/01/2010

Labeler - Corporacion Infarmasa (934098294)

Establishment
Name	Address	ID/FEI	Business Operations
Corporacion Infarmasa		934098294	manufacture