Label: COMFORT-TIME- acetaminophen, caffeine, and pyrilamine maleate tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 14, 2018

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  • ACTIVE INGREDIENT

    active ingredients (in each tablet)


    Acetaminophen 500 mg

    Caffeine 60 mg

    Pyrilamine maleate 15 mg

  • PURPOSE

    active ingredients (in each tablet)


    Acetaminophen 500 mg

    Caffeine 60 mg

    Pyrilamine maleate 15 mg

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of these symptoms associated with menstrual periods:

    cramps
    bloating
    water-weight gain
    headache
    backache
    breast tenderness
    fatigue
    muscle aches

  • WARNINGS

    • Warnings

      Liver warning:

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

      more than 8 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

  • DO NOT USE

    Do not use

    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 DOCTOR

    Ask a doctor before use if you have

    difficulty in urination due to enlargement of the prostate gland
    liver disease
    glaucoma
    a breathing problem such as emphysema or chronic bronchitis

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin
    taking sedatives or tranquilizers

  • WHEN USING

    When using this product

    you may get drowsy
    avoid alcoholic drinks
    excitability may occur, especially in children
    alcohol, sedatives, and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery
    limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

  • STOP USE

    Stop use and ask a doctor if

    new symptoms occur
    redness or swelling is present
    pain gets worse or lasts more than 10 days

  • PREGNANCY 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.

  • OVERDOSAGE

    WARNINGS
    Liver warning:

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

    more than 8 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

  • DOSAGE & ADMINISTRATION

    Uses

    for the temporary relief of these symptoms associated with menstrual periods:

    cramps
    bloating
    water-weight gain
    headache
    backache
    breast tenderness
    fatigue
    muscle aches

  • STORAGE AND HANDLING

    Other information

    store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    use by expiration date on package

  • INACTIVE INGREDIENT

    Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • tcl blister 24 tablets

    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    COMFORT-TIME 
    acetaminophen, caffeine, and pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-347
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code TCL;347
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-347-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product12/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/30/2011
    Labeler - Time Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs, Inc037052099manufacture(49483-347)
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