Label: MENSTRUAL PAIN RELIEF COMPLETE- acetaminophen, pyrilamine maleate, caffeine tablet, film coated

  • NDC Code(s): 83059-0006-1
  • Packager: Shield Pharmaceuticals Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 16, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each liquid-filled capsule)

    Acetaminophen 500 mg
    Caffeine 60 mg
    Pyrilamine maleate 15 mg

  • Purpose

    Pain reliever
    Diuretic
    Antihistamine

  • Uses

    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 4,000 mg of acetaminophen in 24 hours
    • 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
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    If a skin reaction occurs, stop use and seek medical help right away.

  • DO NOT USE

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if youare

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
  • WHEN USING

    When using this product

    • avoid alcoholic beverages
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machiner
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • you may get drowsy
    • 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
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition.

  • 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. In case of overdose, get medical help or contact a Poison Control Center 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

    adults and children 12 years and over:

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 caplets with water
    • repeat every 6 hours, as needed
    • do not exceed 6 caplets per day
    • children under 12 years: ask a doctor
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    aerosil, calcium phosphate, colloidal silicon dioxide, cross carmellose sodium, FD&C yellow #6, hypromellose, isopropyl alcohol, magnesium stearate, methlyene chloride, microcrystalline cellulose, pregelatinized starch, polyethylene glycols, poly vinyl pyrrolidone, povidone, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-373-6981 (toll-free)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Shield Pharmaceuticals Corp.
    Hauppauge, NY 11788

  • PRINCIPAL DISPLAY PANEL

    Menstrual Pain Relief Complete


    Acetaminophen/Caffeine/Pyrilamine maleate

    Pain reliever/Diuretic/Antihistamine

    Carton

    Carton

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL PAIN RELIEF COMPLETE 
    acetaminophen, pyrilamine maleate, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0006
    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)  
    CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLENE CHLORIDE (UNII: 588X2YUY0A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PYRROLIDONE (UNII: KKL5D39EOL)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code S17;M7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83059-0006-11 in 1 CARTON01/16/2024
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/16/2024
    Labeler - Shield Pharmaceuticals Corp (118724924)