ALLEROFF description, usages, side effects, indications, overdosage, supplying and lots more!

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Corporacion Infarmasa

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts



FULL PRESCRIBING INFORMATION

Active ingredient












  • 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 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.

Purpose






  • 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

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Cetirizine Hydrochloride SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16853-1261
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 1 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
SODIUM CITRATE
FD&C RED NO. 40
EDETATE DISODIUM
GLYCERIN
saccharin sodium
sorbitol
water
Strawberry

Product Characteristics

Color
pink (pink)

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 2010-01-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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