CODAR AR- chlorpheniramine maleate, codeine phosphate liquid

Codar by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

• 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 Children12 years of age andover: 2 teaspoonfuls (10 mL); every 4-6 hours, not to; exceed 12 teaspoonfuls; in a 24 hour period.
• Children 6 to under12 years of age: 1 teaspoonful (5 mL); every 4-6 hours, not to ; exceed 6 teaspoonfuls; in a 24 hour period.
• Children under 6years 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

INGREDIENTS AND APPEARANCE

CODAR  AR
chlorpheniramine maleate, codeine phosphate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60575-212
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	2 mg  in 5 mL
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520)	Codeine Phosphate	8 mg  in 5 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60575-212-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/20/2011

Labeler - Respa Pharmaceuticals, Inc. (883901019)