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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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 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
Respa Pharmaceuticals, Inc.