CODAR- codeine phosphate, pseudoephedrine hydrochloride liquid

CODAR by

Drug Labeling and Warnings

CODAR by is a Otc medication manufactured, distributed, or labeled by Respa Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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 Children12 years of age andover: 2 teaspoonfuls (10 mL); every 4-6 hours, not to; exceed 8 teaspoonfuls; in a 24 hour period.
• Children 6 to under12 years of age: 1 teaspoonful (5 mL); every 4-6 hours, not to; exceed 4 teaspoonfuls; in a 24 hour period.
• Children under 6years 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

INGREDIENTS AND APPEARANCE

CODAR   D
codeine phosphate, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60575-515
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520)	Codeine Phosphate	8 mg  in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60575-515-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/13/2011

Labeler - Respa Pharmaceuticals (883901019)