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  5. Label Information: Pro-red AC

FDA Label for Pro-red AC

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF THE REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS? COMMENTS?
    16. PRODUCT PACKAGING

Pro-red 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)

Dexchlorpheniramine Maleate 1 mg

Phenylephrine Hydrochloride 5 mg


Purpose



Antitussive

Antihistamine

Nasal Decongestant


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, watery eyes

Warnings



Do not exceed recommended dosage.


Do Not Use This Product



  • if you are now taking a prescription monoamine oxidase inhibitor (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)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • 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

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



  • 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

Otc - Pregnancy Or Breast Feeding



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


Keep Out Of The 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 older:		2 teaspoonfuls
(10 mL) every
4 hours, not to
exceed 6 doses in a
24 hours.

Children 6

to under 12

years of age:

1 teaspoonful (5 mL)
every 4 hours, not
to exceed 6 doses
in a 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, FD&C Red #40, 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.  1-660-665-0084

(8 a.m. to 5 p.m.)

CV


Product Packaging



Principal display panel and side panel for 473 mL label:

NDC #66594-499-16

CV

PRO-RED AC

SYRUP

ALCOHOL FREE / SUGAR FREE / GLUTEN FREE

ANTITUSSIVE / ANTIHISTAMINE / NASAL DECONGESTANT

Each teaspoonful (5 mL) contains:

CODEINE PHOSPHATE...........................9 mg

*(WARNING: MAY BE HABIT-FORMING)

DEXCHLORPHENIRAMINE

MALEATE...............................................1 mg

PHENYLEPHRINE

HYDROCHLORIDE..................................5 mg

Cotton Candy Flavor

16 FL. OZ. (473 mL)

PRO-PHARMA LLC

"NEW FORMULATION"

Tamper evident by foil seal under cap.  Do not use

if foil seal is broken or missing.

THIS BOTTLE NOT TO BE DISPENSED TO CONSUMER.

Dispense in a tight, light-resistant container with

a child-resistant cap.

Manufactured by:

Pernix Manufacturing, LLC

Houston, TX  77099

Distributed for:

Pro-Pharma, LLC

Kirksville, MO  63501

Rev. 09/13

PRO-RED AC Packaging - MM1

PRO-RED AC Packaging - MM1


* Please review the disclaimer below.