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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 the 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)
Phenylephrine Hydrochloride 3.33 mg
Brompheniramine Maleate 1.33 mg

Purpose

Cough Suppressant

Nasal Decongestant

Antihistamine

M-END Uses

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
• swelling of nasal passages
• runny nose
• itchy, watery eyes
• sneezing

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

• 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
• a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• a cough that occurs with too much phlegm (mucus)

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

When using this product

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

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.
• new symptoms occur

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

Keep out of the reach of children.

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

Directions

Do not exceed recommended dosage.

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, 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 354 mL label:

NDC 12830-0754-12

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CV

EACH 5 mL (1 TEASPOONFUL)

CONTAINS:

Codeine Phospate.......................................6.33 mg
(WARNING:  May be habit-forming.)
Phenylephrine Hydrochloride.......................3.33 mg
Brompheniramine Maleate ..........................1.33 mg


12 fl. oz. (354 mL)

Mfg. for:

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

Rev. 9/08

Tamper evident by foil seal under cap. 

Do notuse if foil seal is broken or missing.

This package not intended for dispensing to the patient.