Pro-clear
FDA Label NDC 66594-333

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pro-pharma Llc for the product Pro-clear (NDC 66594-333). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

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

Purpose

AntitussiveAntihistamine

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

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

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.)CV

Product Packaging:

The packaging below represents the labeling currently used.Principal display panel and side panel for 473 mL label:NDC # 66594-333-16              CVPRO-CLEAR ACSYRUPSUGAR FREE · DYE FREE · ALCOHOL FREE · GLUTEN FREEANTITISSIVE · ANTIHISTAMINEEach teaspoonful (5 mL) contains:CODEINE PHOSPHATE*.............................9 mg*(WARNING: MAY BE HABIT-FORMING)PYRILAMINE MALEATE..........................8.33 mgCotton Candy Flavor16 FL. OZ. (473 mL)PRO-PHARMA LLCTamper 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  77099Distributed for:Pro-Pharma, LLCKirksville, MO  63501Rev. 10/11

* Please review the disclaimer below.