FDA LABEL MFR: Pro-Pharma LLC

Codeine Phosphate 1.8 Mg/ml / Pyrilamine Maleate 1.67 Mg/ml Oral Solution

Table of Contents

Drug Facts
Warnings
Directions
Other information
Inactive ingredients
Questions? Comments?
Product Packaging:

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate* 9 mg
*WARNING: May be habit forming.
Pyrilamine Maleate 8.33 mg

Purpose

Antitussive
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 runny nose sneezing itching of the nose or throat itchy, water eyes

Warnings

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

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

a cough 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 4 hours, not to exceed 6 doses in 24 hours.
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 doses in 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, 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. Call 1-660-665-0084 (8 a.m. to 5 p.m.)

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Product Packaging:

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC # 66594-333-16

CV

PRO-CLEAR AC
SYRUP

SUGAR FREE · DYE FREE · ALCOHOL FREE · GLUTEN FREE

ANTITISSIVE · ANTIHISTAMINE

Each teaspoonful (5 mL) contains:
CODEINE PHOSPHATE*.............................9 mg
*(WARNING: MAY BE HABIT-FORMING)
PYRILAMINE MALEATE..........................8.33 mg

Cotton Candy Flavor

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.

Manufactured by:
Great Southern Laboratories,
Houston, TX 77099

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

Rev. 10/11