CAPCOF (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]

CAPCOF (CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE) LIQUID [CAPITAL PHARMACEUTICAL, LLC]
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NDC 29978-420-15, 29978-420-16
Set ID 1b281052-55e3-42c0-86ae-585799d97960
Category HUMAN OTC DRUG LABEL
Packager Capital Pharmaceutical, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

    Active ingredients

    (in each 5 mL teaspoonful)

    Chlorpheniramine Maleate 2 mg

    Codeine Phosphate* 10 mg

    *(WARNING:  May be habit forming)

    Phenylephrine Hydrochloride 5 mg

  • Purpose

    Antihistamine

    Antitussive

    Nasal Decongestant

  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • reduces swelling of nasal passages
  • 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 breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • 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 or shortness of breath, or children who are taking other drugs
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

  • When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • be careful when driving a motor vehicle or operating machinery
    • may cause or aggravate constipation
  • 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.  A persistent cough may be a sign of a serious condition.
    • 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 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 hours, not to
    exceed 12 teaspoonfuls
    in 24 hours

    .

    Children 6 to under
    12 years of age:


    1 teaspoonful
    (5 mL) every
    4 hours,
    not to exceed
    6 teaspoonfuls in
    24 hours.

    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 side effects for your child.

  • 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.

    CV

  • CapCof 16 fl oz. (473 mL) Bottle Label





    CapCof Label 1CapCof Label 2

  • INGREDIENTS AND APPEARANCE
    CAPCOF 
    codeine phosphate, phenylephrine hydrochloride, chlorpheniramine maleate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29978-420
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    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; Type 0: Not a Combination Product10/08/2010
    2NDC:29978-420-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/201001/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/08/2010
    Labeler - Capital Pharmaceutical, LLC (831545541)