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  5. Label Information: Codar D

FDA Label for Codar D

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. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS? COMMENTS?
    16. PRODUCT PACKAGING

Codar D Product Label

The following document was submitted to the FDA by the labeler of this product Respa Pharmaceuticals. 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* 8 mg*(Warning:  May be habit-forming)Pseudoephedrine Hydrochloride 30 mg

Purpose



Cough SuppressantNasal 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

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 mellitus
  • difficulty in urination 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

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.  These could be signs 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 4-6 hours, not to
exceed 8 teaspoonfuls
in a 24 hour period.
Children 6 to under
12 years of age:
1 teaspoonful (5 mL)
every 4-6 hours, not to
exceed 4 teaspoonfuls
in a 24 hour period.
Children under 6
years of age:
Not recommended
for use.


Other Information



Store at 15°- 30°C (59°- 86°F)

Inactive Ingredients



Berry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions? Comments?



Call (630) 543-3333Rx OnlyCVManufactured for:RESPA® PHARMACEUTICALS, INC.Addison, IL  60101

Product Packaging



The packaging below represents the labeling currently used:Principal display panel and side pane for 473 mL label:NDC 60575-515-16_____________________________________Codar® DCough Suppressant / Nasal Decongestant_____________________________________CVEach 5 mL (one teaspoonful) for oral administration contains:Codeine Phosphate*..............................8 mgPseudoephedrine HCl...........................30 mgBerry FlavorRx OnlyRESPA®PHARMACEUTICALS, INC.Addison, IL  6010116 fl oz. (473 mL)SEE ATTACHED PRODUCT INSERT FOR COMPLETE DOSING INFORMATION.Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.Dispense in a tight, light-resistant containeras defined in the USP/NF with a child-resistantclosure.Store at controlled room temperature, 15°- 30°C(59°- 86°F).KEEP THIS AND ALL MEDICATIONS OUTOF THE REACH OF CHILDREN.Manufactured for:Respa PharmaceuticalsAddison, IL  60101Rx OnlyRev. 06/11

* Please review the disclaimer below.