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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PRO-RED AC SYRUP

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:

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 children
12 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 6
years 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

PRO-RED AC Packaging

PRO-RED AC Packaging

PRO-RED  AC
codeine phosphate, dexchorpheniramine maleate, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66594-499
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) Codeine Phosphate9 mg  in 5 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66594-499-16473 mL in 1 BOTTLE
2NDC:66594-499-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/2013
Labeler - Pro-Pharma, LLC (781088146)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIBusiness Operations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(66594-499)

Revised: 10/2013
Document Id: cc958709-6208-4ae0-8d57-2361bf78d826
Set id: 72355a55-e1b9-4004-9d2d-e215f947946e
Version: 1
Effective Time: 20131007
 
Pro-Pharma, LLC