Codar
FDA Label NDC 60575-212

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Respa Pharmaceuticals, Inc. for the product Codar (NDC 60575-212). 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, do not take this product, unless directed by a doctor before use if you have, ask a doctor before use if you are, 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)Chlorpheniramine Maleate 2 mgCodeine Phosphate* 8 mg*(Warning:  May be habit-forming)

Purpose

AntihistamineAntitussive (Cough Suppressant)

Uses

Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other upper respiratory allergies (allergic rhinitis).  Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants and helps you cough less.

Warnings

Do not exceed recommended dosage.

Do Not Take This Product, Unless Directed By A Doctor Before Use If You Have

  • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • a chronic pulmonary disease, shortness of breath, or children who are taking other drugs
  • a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma
  • difficulty in urination due to enlargement of the prostate gland.

Ask A Doctor Before Use If You Are

Taking sedatives or tranquilizers

When Using This Product

  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • cough 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.
  • may cause or aggravate constipation.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep This And Other Drugs 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
over:

2 teaspoonfuls (10 mL)
every 4-6 hours, not to
exceed 12 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 6 teaspoonfuls
in a 24 hour period.
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 effects for your child.

Other Information

Store at 15°- 30°C (59°- 86°F)

Inactive Ingredients

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

Questions? Comments?

Call (630) 543-3333Rx OnlyCVManufactured for:RESPAPHARMACEUTICALS, INC.Addision, IL  60101

Product Packaging

The packaging below represents the labeling currently used:Principal display panel and side panel for 473 mL label:NDC 60575-212-16_____________________________________________Codar ARAntihistamine / Cough Suppressant_____________________________________________Each 5 mL (one teaspoonful) for oral administration contains:Chloropheniramine Maleate................................2 mgCodeine Phosphate*..........................................8 mg*(Warning:  May be habit-forming)CVApple FlavorRx OnlyRESPAPHARMACEUTICALS, INC.Addision, IL  6010116 fl oz. (473 mL)SEE ATTACHED PRODUCT INSERT FOR COMPLETEDOSING INFORMATION.Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.Store at controlled room temperature, 15°- 30°C (59°- 86°F).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:Respa PharmaceuticalsAddison, IL  60101Rx OnlyRev. 05/11

* Please review the disclaimer below.