Label: HYBRID CF- apap 500 mg phenylephrine hcl 5 mg chlorpheniramine maleate 2 mg tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 3, 2010

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  • ACTIVE INGREDIENT


    Active Ingredients (in each caplet)
    Acetaminophen 500 mg
    Chlorpheniramine maleate 2 mg
    Phenylephrine HCl 5 mg
  • PURPOSE

    Purposes
    Pain reliever/Fever Reducer
    Antihistamine
    Nasal Decongestant


  • DOSAGE & ADMINISTRATION

    Directions

    Adults: Take 1 to 2 caplets with water every 6 hours as needed; do not take more than 8 caplets in 24 hours or as directed by a doctor.

  • INACTIVE INGREDIENT

    Enter section text here

  • QUESTIONS

    Questions? 1-904-367-8437, Monday-Friday, 9am-5pm EST

  • Warnings

    Liver warning: This product contains acetaminophen.  Severe liver damage may occur if you take

    more than 8 caplets in 24 hours

    with other drugs containing acetaminophen

    3 or more alcoholic drinks every day while using this product

    Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.  Acetaminophen may cause liver damage.

  • Do Not Use

    • 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 
    • with any other product containing any of the above active ingredients.
    • with any other drug containing acetaminophen (prescription or nonprescription).
    • Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
  • Ask a doctor or pharmacist before use if

    you are taking sedatives or tranquilizers.

  • When using this product

    • do not use more than directed
    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase the drowsiness
    • use caution when driving a motor vehicle or operating machinery
  • Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • redness of swelling is present
    • new symptoms occur
    • symptoms get worse or last for more than 7 days
    • fever gets worse or lasts more than 3 days
  • 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 immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Hybrid CF

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    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    HYBRID CF 
    apap 500 mg phenylephrine hcl 5 mg chlorpheniramine maleate 2 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49804-101(NDC:62959-116)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (15 CPS) (UNII: 36SFW2JZ0W)  
    TRIACETIN (UNII: XHX3C3X673)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code PAC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49804-101-241 in 1 CARTON
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/03/2010
    Labeler - Hybrid-Rx LLC (794846191)
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