ALLEROFF- cetirizine hydrochloride syrup

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

(in each 5 ml teaspoonful) Cetirizine HCL 5 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

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

See bottom panel for lot number and expiration date

DOSAGE & ADMINISTRATION

Use only with enclosed dosing cup

Adults and Children 6 years and over             1 teaspoonful (5ml) ot 2 teaspoonful (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonful (10ml) in 24        hours

Adults 65 years and over                               1 teaspoonful (5ml) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours

Children 2 to under 6 years of age                   1/2 teaspoonful (2.5ml) once daily.If needed, dose can be increased to a maximum of 1 teaspoon (5ml) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) in 24 hours

Children under 2 years of age                          Ask a Doctor

Consumer with liver or kidney disease             Ask a Doctor

INACTIVE INGREDIENT

Citric and monohydrate, Sodium Benzoate, Sodium Citrate Tribasic Dihydrate, FDC Red Nº 40, Disodium Edetate, Strawberry Essence Liquid, Glycerol, Saccharin Sodium, Sorbitol, Purified Water

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ALLEROFF 
cetirizine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16853-1261
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	1 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.080 mg
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.100 mg
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.090 mg
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.003 mg
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.025 mg
GLYCERIN (UNII: PDC6A3C0OX)	25 mg
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.075 mg
SORBITOL (UNII: 506T60A25R)	30 mg
WATER (UNII: 059QF0KO0R)	100 mL
STRAWBERRY (UNII: 4J2TY8Y81V)	0.07 mg

Product Characteristics
Color	pink (pink)	Score
Shape		Size
Flavor	STRAWBERRY (Strawberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16853-1261-1	1 in 1 CARTON
2	NDC: 16853-1261-2	2 in 1 PACKAGE, COMBINATION

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022155	01/15/2010

Labeler - Corporacion Infarmasa (934098294)

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