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Llorens Pharmaceutical International Division

DRUG FACTS

FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients (in each 5 mL tsp.)

Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine

Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant

Purpose

Uses:

• Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
• Helps decongest sinus openings and sinus passages
• Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
• Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.
  

Warnings:

•  Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.
  

Ask a doctor before use if you are taking sedatives or tranquilizers.

Ask a doctor before use if you have

•  heart disease
• high blood pressure
• thyroid disese
• diabetes
• glucoma
• difficulty in urination due to the enlargement of the prostate gland.

• do not exceed the recommended dosage
• excitability may occur, especially in children
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
  

• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or occur with a fever.
  

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a Health Professional before use.

Directions: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

Uses

Other Information:

• Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap
• Do not use if there is evidence of tampering
• WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.
  

Inactive Ingredients: aspartame, cherry flavor, citric acid, glycerine, menthol, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben and purified water.

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