Label: COLD MEDICINE- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

  • 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 January 25, 2017

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  • Active ingredients (in each tablet)

    Acetaminophen 325 mg

    Chlorpheniramine maleate 2 mg

    Phenylephrine 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.

    Allergy 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 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    ■ liver disease

    ■ heart disease

    ■ glaucoma

    ■ high blood pressure

    ■ thyroid disease

    ■ diabetes

    ■ 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 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 n alcohol, sedatives, and tranquilizers may increase drowsiness

    ■ avoid alcoholic drinks n 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 n pain or nasal congestion gets worse or lasts for more than 7 days

    ■ fever gets worse or lasts for more than 3 days

    If pregnant or breast-feeding,

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Keep out of reach of children.  In case of overdose, 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 6 hours.  Do not take more than 12 tablets in 24 hours.

    ■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) 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

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

  • Questions and comments?

    1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

  • Principal Display Panel

    XL-3 Cold Medicine

    XL-3 Cold Medicine

     

  • INGREDIENTS AND APPEARANCE
    COLD MEDICINE 
    acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-275
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;275
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-275-202 in 1 CARTON11/15/2011
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/15/2011
    Labeler - Selder, S.A. de C.V. (824413629)
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