Codar

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each 5 mL teaspoonful)
Chlorpheniramine Maleate 2 mg
Codeine Phosphate^* 8 mg
*(Warning:  May be habit-forming)

Purpose

OTC - PURPOSE SECTION

Antihistamine
Antitussive (Cough Suppressant)

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not take this product, unless directed by a doctor before use if you have

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and other drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at 15°- 30°C (59°- 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions? Comments?

OTC - QUESTIONS SECTION

Call (630) 543-3333

Rx Only

CV

Manufactured for:

RESPA
PHARMACEUTICALS, INC.

Addision, IL  60101

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• Codar AR
• Chlorpheniramine Maleate, Codeine Phosphate
• Chlorpheniramine Maleate
• Chlorpheniramine
• Codeine Phosphate
• Codeine
• Citric Acid
• Propylene Glycol
• Water
• Sodium Citrate
• Saccharin Sodium
• Sorbitol

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 247 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.