Alleroff Syrup Drug Facts

Generic Name: cetirizine hydrochloride

Dosage Form: syrup
Drug Facts

(in each 5 ml teaspoonful) Cetirizine HCL 5 mg..........Antihistamine


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:

• 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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hidroxyzine

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

If pregnant or breast feeding:

• if breast feeding: not recommended


• if pregnant: ask a health professional before use

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

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

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

Questions or comments? 561 338 5221

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

See bottom panel for lot number and expiration date

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

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

ALLEROFF  cetirizine hydrochloride  syrup

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (Cetirizine) CETIRIZINE HYDROCHLORIDE 1 mg

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE 0.080 mg SODIUM BENZOATE 0.100 mg SODIUM CITRATE 0.090 mg FD&C RED NO. 40 0.003 mg EDETATE DISODIUM 0.025 mg GLYCERIN 25 mg SACCHARIN SODIUM 0.075 mg SORBITOL 30 mg WATER 100 mL STRAWBERRY 0.07 mg

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

Packaging # NDC Package Description Multilevel Packaging 1 16853-1261-1 1 BOTTLE In 1 CARTON None 2 16853-1261-2 2 BOTTLE In 1 PACKAGE, COMBINATION None

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	Operations
Corporacion Infarmasa		934098294	manufacture

Revised: 01/2010Corporacion Infarmasa

More Alleroff Syrup Drug Facts resources

• Alleroff Syrup Drug Facts Side Effects (in more detail)
• Alleroff Syrup Drug Facts Dosage
• Alleroff Syrup Drug Facts Use in Pregnancy & Breastfeeding
• Alleroff Syrup Drug Facts Drug Interactions
• Alleroff Syrup Drug Facts Support Group
• 0 Reviews for Alleroff Drug Facts - Add your own review/rating

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