Label: ACETAMINOPHEN 500 PYRILAMINE MALEATE 15 AND CAFFEINE 60- acetaminophen 500mg pyrilamine maleate 15mg and caffeine 60mg tablets tablet, film coated

  • NDC Code(s): 71679-312-00, 71679-312-20
  • Packager: Health Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 8, 2026

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

  • Active ingredient (in each caplet)

    Active ingredient (in each caplet) Purpose

    Acetaminophen 500mg..............Pain reliever/Fever reduce
    Caffeine 60 mg.............................................................Diuretic
    Pyrilamine maleate 15 mg....................................Antihistamine

  • Purpose

    Pain reliever/Fever reduce
    Diuretic
    Antihistamine

  • Uses

    Uses:
    ■ for the temporary relief of these symptoms
    associated with menstrual periods: ■ cramps
    ■ bloating ■ water-weight gain ■ headache
    ■ backache ■ muscle aches ■ fatigue

  • Warning

    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 for this product
    ■ with other drugs containing acetaminophen
    ■ 3 or more alcoholic drinks every day while using this
    product Allergy warning: acetaminophen may cause severe
    skin 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

    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

    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 your doctor or pharmacist before use if you are

    ask your 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 appear ■
    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. 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.

  • When using this product

    When using this product■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery, this
    product will cause drowsiness

  • Stop use and ask doctor if

    Stop use and ask a doctor if:■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be
    a symptom of serious underlying medical illness. ■ pain gets worse or lasts more than 10 days ■ fever gets
    worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur.
    These could be signs of a serious condition.

  • If pregnant or breast-feeding

    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) right away.
    Prompt medical attention is critical for adults as well as for children even if you do not notice any signs
    or symptoms.

  • Directions

    Directions

    ■ do not exceed recommended dosage. ■ adults and
    children 12 years and over: take 2 tablets with water. Repeat
    every 6 hours, as needed do not exceed 6 tablets per day
    ■ children under 12 years: consult a doctor

  • Other Information

    Other Information
    ■ Store at controlled room temperature 20°-25°C (68°-77°F).
    ■ Read all product information before use.
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Inactive ingredients

    Inactive ingredients:Colloidal Silicon Dioxide, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Purified Water, Stearic Acid Powder, Talc, Titanium Dioxide.

  • Questions or comments?

    Questions or comments?
    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

  • PRINCIPAL DISPLAY PANEL

    71679-312-00-Bulk Label

    71679-312-20-Midol Complete-20s- Peel off Label-100cc

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500 PYRILAMINE MALEATE 15 AND CAFFEINE 60 
    acetaminophen 500mg pyrilamine maleate 15mg and caffeine 60mg tablets tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-312
    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
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ACETAMINOPHEN (UNII: 362O9ITL9D) 500 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code HH7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-312-0028500 in 1 BOX; Type 0: Not a Combination Product03/07/2024
    2NDC:71679-312-2020 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/07/2024
    Labeler - Health Pharma USA LLC (080804485)
    Registrant - Health Pharma USA LLC (080804485)