OTC - ACTIVE INGREDIENT

Chlorpheniramine Maleate 0.286 mg/1mL: antihistamine; Codeine Phosphate 1 mg/1mL: cough suppressant; Pseudoephedrine Hydrochloride 4.286 mg/1mL: decongestant

PURPOSE

Temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants; the intensity of coughing; the impulse to cough to help you go to sleep; temporarily relieves nasal congestion due to a cold; temporarily restores freer breathing through the nose; temporarily decreases runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies

Warnings

OTC - DO NOT USE

in children who have chronic pulmonary disease, shortness of breath, or who are taking other drugs unless directed by a doctor; for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor; if taking a monoamine oxidase inhibitor (MAOI)

OTC - ASK DOCTOR

if your child has glaucoma, a breathing problem such as emphysema or chronic bronchitis, heart disease, high blood pressure, thyroid disease, diabetes.

OTC - ASK DOCTOR/PHARMACIST SECTION

if you or your child are taking sedatives or tranquilizers; if you or your child are taking prescription MAOI (certain drugs for depression, psychiatric, or emotional conditions), or for 2 weeks after stopping the MAOI drug.

OTC - WHEN USING THIS PRODUCT

do not exceed recommended dosage; may cause or aggravate constipation; may cause excitability in children; may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

OTC - STOP USE AND ASK A DOCTOR IF

cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  These could be signs of a serious condition.

OTC - KEEP THESE AND ALL DRUGS OUT OF REACH OF CHILDREN

In case of overdose, seek professional assistance for contact a Poison Control Center immediately.

Directions:

• Take every 4-6 hours

• Use only with enclosed calibrated oral dispenser

• Do not take more than 4 doses in 24 hours or as directed by a doctor

Children 2 to under 6 years of age:  ask a doctor

Other information store at controlled room temperature 20°-25°C (68°-77°F).

INACTIVE INGREDIENT

citric acid, FD&C blue#1, galloquinate, glycerin, grape flavor, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, xanthan gum

OTC – QUESTIONS SECTION

Call 1-866-574-8861 24 hours a day, 7 days a week.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1.  Primary Label- Front Page

Figure 2. Primary Label – Second Page

Figure 3. Primary Label – Last Page