Alleroff
FDA Label NDC 16853-1261

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Corporacion Infarmasa for the product Alleroff (NDC 16853-1261). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - ask doctor, otc - ask doctor/pharmacist, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, otc - stop use, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

Otc - Ask Doctor

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a differentdose.

Otc - 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

Otc - 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

Otc - 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)


Otc - Pregnancy Or Breast Feeding


If pregnant or breast feeding:

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

Otc - Stop Use

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

Otc - 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

Otc - 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 20°C to 25°C ( 68°F to 77°F)

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 N° 40, Disodium Edetate, Strawberry Essence Liquid, Glycerol, Saccharin Sodium, Sorbitol, Purified Water

Package Label.Principal Display Panel

Image Of Carton Label (Alleroff Jar)

Image Of Carton Label (Alleroff Jar)

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