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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CapCof

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



CapCof Packaging


CapCof Packaging


CAPCOF 
codeine phosphate, phenylephrine hydrochloride, chlorpheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:29978-420
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine) Codeine Phosphate10 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate2 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29978-420-16473 mL in 1 BOTTLE
2NDC:29978-420-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/08/2010
Labeler - Capital Pharmaceutical, LLC (831545541)

Revised: 12/2010
 
Capital Pharmaceutical, LLC