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R.A. McNeil Company
Pernix Manufacturing, LLC

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FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• M-END Uses
• Warnings
  • Do not use this product
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• M-END Other information
• Inactive ingredients
• Questions? Comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate* 6.33 mg
*WARNING:  May be habit-forming
Pseudoephedrine Hydrochloride 10 mg
Brompheniramine Maleate 1.33 mg

Purpose

Antitussive

Cough Suppressant

Nasal Decongestant

Antihistamine

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

• cough due to minor throat and bronchial irritation
• nasal congestion
• reduces swelling of nasal passages
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Do not use this product

• if you are now 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

• a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• a cough that occurs with too much phlegm (mucus)
• chronic pulmonary disease or shortness of breath, or children who are taking other drugs
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

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

When using this product

• excitability may occur, especially in children
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough or nasal congestion 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.
• may cause or aggravate constipation
• new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

Not recommended for children under 6 years of age.

M-END Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Citric Acid, Cotton Candy Flavor, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol

Questions? Comments?

Call 1-423-493-9170

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 12830-0735-16

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Antitussive / Decongestant

Antihistamine

Sugar Free / Alcohol Free

CV

EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Codeine Phosphate...........................6.33 mg

(WARNING: May be habit-forming.)

Pseudoephedrine Hydrochloride...........10 mg

Brompheniramine Maleate..................1.33 mg

Cotton Candy Flavor

ONE PINT (473 mL)

Mfg. for:

R.A. McNeil Company
Chattanooga, TN  37406-3738

Rev. 04/09

Tamper evident by foil seal under cap.  Do not
use if foil seal is broken or missing.

Supplied in a tight, light-resistant container

with a child resistant cap.

This package not intended for dispensing to the patient.

Manufactured for:

R.A. McNeil Company

1150 Latta Street

Chattanooga, TN 37406-3738

Rev. 04/09