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FDA LABEL GENERIC: Chlophedianol MFR: Pro-Pharma, LLC

Chlophedianol Hcl 12.5 Mg / Phenylephrine Hcl 5 Mg / Pyrilamine Maleate 12.5 Mg In 5 Ml Oral Solution

Table of Contents

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 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