PRO-RED AC- codeine phosphate, dexchorpheniramine maleate, phenylephrine hydrochloride syrup

PRO-RED by

Drug Labeling and Warnings

PRO-RED by is a Otc medication manufactured, distributed, or labeled by Pro-Pharma, LLC, Pernix Manufacturing, LLC, Pernix Manufacturing, LLC dba Great Southern Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Codeine Phosphate 9 mg

*(WARNING:  MAY BE HABIT-FORMING)

Dexchlorpheniramine Maleate 1 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Antitussive

Antihistamine

Nasal Decongestant

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
• 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
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma

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

When using this product

• may cause or aggravate constipation
• excitability may occur, especially in children
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• 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.  A persistent cough may be a sign 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.

• Adults and children12 years of age and older: 2 teaspoonfuls; (10 mL) every; 4 hours, not to; exceed 6 doses in a; 24 hours.
• Children 6 to under 12 years of age: 1 teaspoonful (5 mL); every 4 hours, not; to exceed 6 doses; in a 24 hours.
• Children under 6years of age:

  Consult a doctor.

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.  Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

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?

Serious side effects associated with use of this product may be reported to this number.  1-660-665-0084

(8 a.m. to 5 p.m.)

CV

Product Packaging

Principal display panel and side panel for 473 mL label:

NDC #66594-499-16

CV

PRO-RED AC

SYRUP

ALCOHOL FREE / SUGAR FREE / GLUTEN FREE

ANTITUSSIVE / ANTIHISTAMINE / NASAL DECONGESTANT

Each teaspoonful (5 mL) contains:

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

*(WARNING: MAY BE HABIT-FORMING)

DEXCHLORPHENIRAMINE

MALEATE...............................................1 mg

PHENYLEPHRINE

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

Cotton Candy Flavor

16 FL. OZ. (473 mL)

PRO-PHARMA LLC

"NEW FORMULATION"

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:

Pernix Manufacturing, LLC

Houston, TX  77099

Distributed for:

Pro-Pharma, LLC

Kirksville, MO  63501

Rev. 09/13

INGREDIENTS AND APPEARANCE

PRO-RED  AC
codeine phosphate, dexchorpheniramine maleate, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66594-499
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Codeine Phosphate (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	Codeine Phosphate	9 mg  in 5 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66594-499-16	473 mL in 1 BOTTLE
2	NDC: 66594-499-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/30/2013

Labeler - Pro-Pharma, LLC (781088146)

Registrant - Pernix Manufacturing, LLC (078641814)

Establishment
Name	Address	ID/FEI	Business Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories		078641814	manufacture(66594-499)