Label: COLD MEDICINE XL3 FORTE- acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet

  • NDC Code(s): 63654-601-01, 63654-601-02, 63654-601-04, 63654-601-10, view more
    63654-601-20, 63654-601-50
  • Packager: Selder, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

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 October 14, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients (in each tablet)

    Acetaminophen 325 mg
    Chlorpheniramine maleate 4 mg
    Phenylepherine HCl 10 mg

  • Purposes

    Pain reliever/fever reducer
    Antihistamine
    Nasal decongestant

  • Uses

    temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 tablets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

    Alergy alert acetaminophen may cause severe skin reactions. Symptoms may include ■ skin reddening ■ blisters ■ rash

    If a skin reaction occurs, stop use and seek medical help right away

  • Do not use

    ■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins an MAOI, ask a doctor or pharmacist before taking this product. ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • Ask adoctor before use if you have

    ■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis

  • Ask a doctor or pharmacist before use if you

    ■ are taking the blood thinning drug warfarin ■ are taking sedatives or tranquilizers

  • When using this product

    do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery

  • Stop use and ask a doctor if

    ■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days

  • Keep out of reach of children

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

  • Other Information

    ■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged

  • Inactive Ingredients

    Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive

  • Questions and Comments?

    You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    COLD MEDICINE  XL3 FORTE
    acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Coloryellow (light yellow) Scoreno score
    ShapeROUND (Tablet) Size5mm
    FlavorImprint Code XL3;FORTE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-601-5050 in 1 BOX08/01/2017
    1NDC:63654-601-044 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:63654-601-202 in 1 BOX08/01/2017
    2NDC:63654-601-0210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63654-601-101 in 1 BOX10/12/2018
    3NDC:63654-601-0110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01208/01/2017
    Labeler - Selder, S.A. de C.V. (824413629)
    Establishment
    NameAddressID/FEIBusiness Operations
    Selder, S.A. de C.V.824413629manufacture(63654-601)