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

PRO-CHLO by

Drug Labeling and Warnings

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

Drug Details [pdf]

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:

• 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, water eyes
  

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 12years of ageand over: 2 teaspoonfuls (10 mL); every 6 hours, not to; exceed 8 teaspoonfuls in; 24 hours
• Children 6 tounder 12 yearsof age: 1 teaspoonful (5 mL); every 6 hours, not to; exceed 4 teaspoonfuls in; 24 hours
• Children under6 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66594-321
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlophedianol Hydrochloride (UNII: 69QQ58998Y) (Chlophedianol - UNII:42C50P12AP)	Chlophedianol Hydrochloride	12.5 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg  in 5 mL
Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL)	Pyrilamine Maleate	12.5 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: 66594-321-16	473 mL in 1 BOTTLE
2	NDC: 66594-321-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/12/2011

Labeler - Pro-Pharma, LLC (781088146)

Registrant - Great Southern Laboratories (056139553)

Establishment
Name	Address	ID/FEI	Business Operations
Great Southern Laboratories		056139553	manufacture