CODAR AR- chlorpheniramine maleate, codeine phosphate liquid 
Respa Pharmaceuticals, Inc.

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.

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Codar AR

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

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

Purpose

Antihistamine
Antitussive (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

Ask a doctor before use if you are

taking sedatives or tranquilizers

When using this product

Stop use and ask a doctor if

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) 543-3333

Rx Only

CV

Manufactured for:

RESPA
PHARMACEUTICALS, 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 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 Packaging


Codar AR Packaging





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 (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate2 mg  in 5 mL
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate8 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid (UNII: 2968PHW8QP)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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: 6/2011
Document Id: 62ec8ee2-4187-48d6-861b-1e586b529912
Set id: acc21b1e-729c-4004-820f-5edbde869458
Version: 1
Effective Time: 20110620
 
Respa Pharmaceuticals, Inc.