PRO-CLEAR AC SYRUP

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antitussive
Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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
  

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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
  

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at 59°-86°F (15°-30°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

OTC - QUESTIONS SECTION

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.)

CV

Product Packaging:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• PRO-CLEAR AC
• Codeine Phosphate and Pyrilamine Maleate
• Codeine Phosphate
• Codeine
• Pyrilamine Maleate
• Pyrilamine
• Citric Acid
• Glycerin
• Propylene Glycol
• Water
• Sodium Citrate
• Saccharin Sodium
• Sorbitol

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 322 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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Adverse event summaries are temporarily unavailable. Other product information remains available.