PRO-CHLO - chlophedianol hydrochloride, phenylephrine hydrochloride, pyrilamine maleate liquid 
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-CHLO LIQUID

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Chlophedianol HCl 12.5 mg
Phenylephrine HCl 5 mg
Pyrilamine Maleate 12.5 mg

Purpose

Antitussive
Nasal Decongestant
Antihistamine

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 inhibibor (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)
  • 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

  • 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 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 over:
2 teaspoonfuls (10 mL)
every 6 hours, not to
exceed 8 teaspoonfuls in
24 hours
Children 6 to
under 12 years
of age:

1 teaspoonful (5 mL)
every 6 hours, not to
exceed 4 teaspoonfuls in
24 hours
Children under
6 years of age:
Consult a doctor.

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

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

Questions? Comments?

Call 1-660-665-0084

Product Packaging

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC #66594-321-16

PRO-CHLO
LIQUID

ALCOHOL FREE·GLUTEN FREE·SUGAR FREE

ANTITUSSIVE · NASAL DECONGESTANT
· ANTIHISTAMINE

Each teaspoonful (5 mL) contains:

CHLOPHEDIANOL HCL...............................12.5 mg
PHENYLEPHRINE HCL....................................5 mg
PYRILAMINE MALEATE..............................12.5 mg

Cotton Candy Flavor

PATENT PENDING

16 FL. OZ. (473 mL)

PRO-PHARMA LLC

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

Dispense in a tight, light-resistant container with a child-resistant
cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

Patent Pending

Manufactured by:
Great Southern Laboratories,
Houstin, TX  77099

Distributed for:
Pro-Pharma, LLC
Kirksville, MO  63501

Iss. 10/11
PRO-CHLO LIQUID PACKAGING

PRO-CHLO LIQUID PACKAGING





PRO-CHLO 
chlophedianol hydrochloride, phenylephrine hydrochloride, pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66594-321
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP) Chlophedianol Hydrochloride12.5 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg  in 5 mL
Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate12.5 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:66594-321-16473 mL in 1 BOTTLE
2NDC:66594-321-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/12/2011
Labeler - Pro-Pharma, LLC (781088146)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIBusiness Operations
Great Southern Laboratories056139553manufacture

Revised: 11/2011
Document Id: 43da4965-15ef-4716-95a6-ea67a636ae43
Set id: c767a626-a3ce-490c-a511-00749784acab
Version: 1
Effective Time: 20111116
 
Pro-Pharma, LLC