Flucur

Chlorpheniramine Maleate:

• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Flucur (Chlorpheniramine Maleate) reviews

Drug Facts

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product in a child who is

• now taking a prescription monoamine oxidase inhibitor (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 your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if a child has

• a breathing problem such as chronic bronchitis
• glaucoma
• heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus

Ask a doctor before use if a child is taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• sedatives and tranquilizers may increase drowsiness effect

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• new symptoms occur

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Questions? Comments?

Call 1-800-543-9560

Rev. 05/11

E

NEW

FORMULA

NDC 00485-0096-02

Flucur (Chlorpheniramine Maleate)

Pediatric Drops

Antihistamine ▪ Nasal Decongestant

Sugar Free ▪ Alcohol Free ▪ Gluten Free

FOR PROFESSIONAL USE ONLY

Each 1 mL for oral administration

contains:

Flucur (Chlorpheniramine Maleate) Maleate

2 mg

Phenylephrine HCl

5 mg

APPLESAUCE FLAVOR

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

2 fl. oz. (60 mL)

Naphazoline Hydrochloride:

• Flucur (Naphazoline Hydrochloride) reviews

Flucur (Naphazoline Hydrochloride) OPHTHALMIC SOLUTION USP, 0.1%

Naphazoline HCl, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. The active ingredient is represented by the structural formula:

Chemical Name:2-(1-naphthylmethyl)-2-imidazoline monohydrochlorideVASOCON REGULAR ophthalmic solution is a sterile solution containing 1 mg/mL Flucur (Naphazoline Hydrochloride) in an isotonic solution containing polyethylene glycol 8000, sodium chloride, polyvinyl alcohol, edetate disodium and purified water; preserved with benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide added to adjust pH. It has a pH of 5.5 to 7.0.CLINICAL PHARMACOLOGY

Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha adrenergic receptors in the arterioles of the conjunctiva resulting in decreased conjunctival congestion. Naphalozine belongs to the imidazoline class of sympathomimetics.

INDICATIONS AND USAGE

Flucur (Naphazoline Hydrochloride) REGULAR is indicated for use as a topical ocular vasoconstrictor.

CONTRAINDICATIONS

Contraindicated in the presence of an anatomically narrow angle or in narrow angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.

WARNINGS

Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.

PRECAUTIONSGeneral

Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, ocular infection or injury and when other medications are being used.

Patient Information

Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring, or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.

To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.Drug Interactions

Concurrent use of maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug..

Pregnancy Category C

Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.

Nursing Mothers

If is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established. See “WARNINGS” and “CONTRAINDICATIONS”.

ADVERSE REACTIONSOcular

Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.

Systemic

Dizziness, headache, nausea, sweating, nervousness drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.

DOSAGE AND ADMINISTRATION

Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.

HOW SUPPLIED

Flucur (Naphazoline Hydrochloride) REGULAR (naphazoline hydrochloride ophthalmic solution USP, 0.1%): 15 mL plastic squeeze bottle with dropper tip. NDC 58768-844-15 To be dispensed only in original, unopened container. Store at controlled room temperature 15°-30°C (59°-86°F).

CAUTION: Federal law prohibits dispensing without prescription. Mfd. by OMJ Pharmaceuticals, Inc.,San Germán, P.R., 00683 for:CIBA VisionOphthalmics^®___________________Atlanta, Georgia 301556072-A