Label: ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG tablet

  • 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 July 5, 2019

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

  • ACTIVE INGREDIENT

    Acetaminophen 500mg

    Caffeine 60mg

    Pyrilamine maleate 15mg

  • INACTIVE INGREDIENT

    ammonium hydroxide, croscarmellose sodium, D&C red No. 33 aluminum lake, ethyl cellulose, FD&C blue No. 1 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, light mineral oil, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch, propylene glycol, shellac glaze, sorbitol sorbitan, talc, titanium dioxide, triacetin

  • DOSAGE & ADMINISTRATION

    • Do not take more than the recommended dose
    • Adults and children 12 years and over: take 2 gelcaps with water, repeat every 6 hours, as needed; do not exceed 6 gelcaps per day
    • Children under 12 years: consult a doctor

  • INDICATIONS & USAGE

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

    Cramps, bloating water-weight gain, headache, backache, muscle aches, fatigue.

  • WARNINGS

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

    Allergy alert: Acetaminophen may cause severe skin reactions or severe allergic reactions. Symptoms may include: skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), shock. If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    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, if you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have liver disease, glaucoma, difficulty in urination due to enlargement of the 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, taking sedatives or tranquilizers.

    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 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 and ask a doctor if new symptoms occur, redness or swelling is present, pain gets worse or lasts for more than 10 days, fever gets worse or lasts for more than 3 days.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PURPOSE

    Pain reliever

    Nighttime sleep-aid

  • OTHER SAFETY INFORMATION

    Store at room temperature between 20-25 ºC (68-77 ºF)

  • PRINCIPAL DISPLAY PANEL

    CT31024

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG 
    acetaminophen 500mg caffeine 60mg pyrilamine maleate 15mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POVIDONE (UNII: FZ989GH94E)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SHELLAC (UNII: 46N107B71O)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorblue (DARK BLUE and LIGHT BLUE) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code S79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2310-2424 in 1 PACKAGE; Type 0: Not a Combination Product07/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/05/2019
    Labeler - WALGREENS CO. (008965063)