PRO-RED

Pro-Pharma, LLC
Great Southern Laboratories

PRO-RED AC SYRUP

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• PRO-RED 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
• PRO-RED Other information
• Inactive ingredients
• Questions? Comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Codeine Phosphate 9 mg

*(WARNING:  MAY BE HABIT-FORMING)

Phenylephrine Hydrochloride 5 mg

Pyrilamine Maleate 8.33 mg

Purpose

Antitussive

Decongestant

Antihistamine

PRO-RED 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
• reduces swelling of nasal passages
• runny nose
• sneezing
• itching of the nose or throat, and, 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
• a breathing problem such as emphysema or chronic bronchitis
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• 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
• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• may cause or aggravate constipation
  

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
  

Keep out of the reach of children.

Directions

PRO-RED 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 1-888-535-0305

CV

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC #66594-444-16

CV

PRO-RED AC

SYRUP

ALCOHOL FREE / SUGAR FREE

ANTITUSSIVE / DECONGESTANT / ANTIHISTAMINE

Each teaspoonful (5 mL) contains:

CODEINE PHOSPHATE...........................9 mg

*(WARNING: MAY BE HABIT-FORMING)

PHENYLEPHRINE

HYDROCHLORIDE..................................5 mg

PYRILAMINE MALEATE......................8.33 mg

Cotton Candy Flavor

16 FL. OZ. (473 mL)

Rx PRO-PHARMA

Tamper evident by foil seal under cap.  Do not use

if foil seal is broken or missing.

THIS BOTTLE NOT TO BE DISPENSED TO CONSUMER.

Dispense in a tight, light-resistant container with

a child-resistant cap.

Manufactured by:

Great Southern Laboratories

Houston, TX  77099

Distributed for:

Pro-Pharma, LLC

Kirksville, MO  63501

Iss. 03/09