Pill Identifier App

Codar AR

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 2mg in 5mL, Codeine Phosphate 8mg in 5mL
Labeler: Respa Pharmaceuticals, Inc.
NDC Code: 60575-212

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Codar AR

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 2 mg
Codeine Phosphate* 8 mg
*(Warning:  May be habit-forming)

PurposeAntihistamine
Antitussive (Cough Suppressant)

Usestemporarily 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 aretaking 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 informationStore at 15°- 30°C (59°- 86°F)

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

Questions? Comments?Call (630) 543-3333

Rx Only

CV

Manufactured for:

RESPA
PHARMACEUTICALS, INC.


Addision, IL  60101

Product PackagingThe packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 60575-212-16
_____________________________________________

Codar AR

Antihistamine / Cough Suppressant
_____________________________________________

Each 5 mL (one teaspoonful) for oral
administration contains:

Chloropheniramine Maleate................................2 mg
Codeine Phosphate*..........................................8 mg
*(Warning:  May be habit-forming)

CV

Apple Flavor

Rx Only

RESPA
PHARMACEUTICALS, INC.

Addision, IL  60101

16 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 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 Pharmaceuticals
Addison, IL  60101

Rx Only

Rev. 05/11








CODAR  AR
chlorpheniramine maleate, codeine phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60575-212
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate2 mg  in 5 mL
Codeine Phosphate (Codeine) Codeine Phosphate8 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60575-212-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/20/2011
Labeler - Respa Pharmaceuticals, Inc. (883901019)

Revised: 06/2011
 
Respa Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)