CODAR  D- codeine phosphate, pseudoephedrine hydrochloride liquid 
Respa Pharmaceuticals

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 D

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Codeine Phosphate* 8 mg
*(Warning:  May be habit-forming)
Pseudoephedrine Hydrochloride 30 mg

Purpose

Cough Suppressant
Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

Do not exceed recommended dosage.

Do not use this product

Ask a doctor before use if you have

Ask a doctor or pharmacist 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 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) 543-3333

Rx Only

CV

Manufactured 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® D

Cough Suppressant / Nasal Decongestant
_____________________________________


CV

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

Codeine Phosphate*..............................8 mg
Pseudoephedrine HCl...........................30 mg

Berry Flavor

Rx Only

RESPA®
PHARMACEUTICALS, INC.
Addison, 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. 06/11

Codar D Packaging


Codar D Packaging

CODAR   D
codeine phosphate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60575-515
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate8 mg  in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60575-515-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/2011
Labeler - Respa Pharmaceuticals (883901019)

Revised: 7/2011
Document Id: 076f7810-5c2b-4d9b-9a69-4308cb9440ca
Set id: ed5fe2aa-a6cd-4607-834f-c08593b05792
Version: 1
Effective Time: 20110726
 
Respa Pharmaceuticals