CAPCOF - codeine phosphate, phenylephrine hydrochloride and chlorpheniramine maleate liquid
Capital Pharmaceutical, LLC
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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Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg
Purpose
Antitussive, Nasal Decongestant, Antihistamine
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
- sneezing
- itching of the nose or throat
- itchy, watery eyes
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, shortness of breath, or children who are taking other drugs
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating 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 marked drowsiness
- avoid alcoholic drinks
- 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
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1week, 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
- 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 of Poison Control Center right away.
Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over:
| 1-2 teaspoonfuls (5-10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in a 24 hour period
|
Children 6 to under 12 years of age:
| 1/2-1 teaspoonful (2.5-5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in a 24 hour period
|
Children under 6 years of age:
| Consult a doctor
|
Other information
Store at 59° - 86°F (15° - 30°C)
Inactive ingredients
Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
Questions? Comments?
Call 1-614-638-4622.
Product Packaging
The packaging below represents the labeling currently used.
Principal display panel and side pane for 473 mL label:
NDC 29978-420-16
CapCof
Antitussive / Nasal Decongestant / Antihistamine
Each 5 mL (one teaspoonful) for oral administration contains:
Codeine Phosphate
*.....................................10 mg
*(WARNING-May be habit forming)
Phenylephrine Hydrochloride...........................5 mg
Chlorpheniramine Maleate...............................2 mg
Cotton Candy Flavor
CV
CAPITAL pharmaceutical
16 fl oz. (473 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container with a child-resistant cap.
This bottle is not to be dispensed to consumer.
Manufactured by: Great Southern Laboratories, Houston, TX 77099
Manufactured for: Capital Pharmaceutical, LLC, Radnor, OH 43066
Iss. 09/10