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  5. Label Information: Pro-clear AC

FDA Label for Pro-clear AC

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS? COMMENTS?
    15. PRODUCT PACKAGING:

Pro-clear AC Product Label

The following document was submitted to the FDA by the labeler of this product Pro-pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.