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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients (in each tablet)

    Acetaminophen 325 mg
    Chlorpheniramine maleate 2 mg
    Phenylepherine HCl 5 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 12 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 ■ 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 contains 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.Prompt 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 ■ Adults and children 12 years of age and older: take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) and may cause liver damage.

  • Other Information

    ■ store at room temperature in a dry place ■ do not use if blister package is torn.

  • Inactive Ingredients

    alcohol, croscarmellose sodium, hypromellose, lactose monhydrate (derived from milk), magnesium stearate, polyethylene glycol, purified water, talc, titanium dioxide

  • Questions and Comments?

    1-855-259-1590 Monday through Friday 9AM-5PM EST

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    COLD MEDICINE  XL3
    acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-605
    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 MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Tablet) Size11mm
    FlavorImprint Code XL3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-605-202 in 1 BOX06/27/2022
    110 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 DrugM01206/27/2022
    Labeler - Selder, S.A. de C.V. (824413629)
    Establishment
    NameAddressID/FEIBusiness Operations
    Selder, S.A. de C.V.824413629manufacture(63654-605)