Label: ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE tablet

  • NDC Code(s): 24689-121-01, 24689-121-02
  • Packager: APNAR PHARMA LP
  • 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 June 24, 2022

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

  • BOXED WARNING (What is this?)

    Caution: Do not use if imprinted seal under cap is broken or missing

  • ACTIVE INGREDIENT

    Drug facts

    Active Ingredient (in each tablet)


    Acetaminophen USP....... 500 mg

    Caffeine USP....................60 mg

    Pyrilamine Maleate USP......15 mg

  • PURPOSE

    Purpose

    Pain reliever/Diuretic/Antihistamine

  • INDICATIONS & USAGE

    Use(s)

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

    • cramps
    • bloating
    • water-weight gain
    • headache
    • backache
    • muscle aches
    • fatigue
  • WARNINGS

    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 Alert:

    Acetaminophen may cause severe skin or severe allergy 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 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 more than 10 days
    • fever get worse or lasts more than 3 days

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

    Overdose warning
    In case of overdose, get medical help or contact a poison control center 1-800-222-1222 right away. Quick medical help attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than the recommended dose
    • adults and children 12 years of age or older: take 2 tablets with water
    • repeat every 6 hours or as needed
    • do not exceed 6 tablets per day
    • children under 12 years: consult a doctor
  • STORAGE AND HANDLING

    Other Information

    • Store at 15° - 30°C (59° – 86° F).
  • INACTIVE INGREDIENT

    Inactive Ingredients

    pregelatinized starch, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, talc

  • QUESTIONS

    Questions or comments?

    1-855-642-2594

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Apnar Pharma LP

    CHINO, CA, 91710

    Rev.: 05/2022

    †This product is not manufactured or distributed by Bayer Healthcare, LLC owner of the registered trademark Midol Complete®

  • PRINCIPAL DISPLAY PANEL

    APNAR PHARMA LP

    NDC: 24689-121-01

    Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets -20's Tablets

    ACP tablet-20s tablets

    APNAR PHARMA LP

    NDC: 24689-121-02

    Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets -500's Tablets

    ACP tablets-500s

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN,CAFFEINE AND PYRILAMINE MALEATE 
    acetaminophen,caffeine and pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-121
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    Colorwhite (white to off-white) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code LT16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-121-0120 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2022
    2NDC:24689-121-02500 in 1 BOTTLE; Type 0: Not a Combination Product07/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/05/2022
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVAHEALTH INC116840615label(24689-121) , pack(24689-121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apnar Pharma Private Limited876730408analysis(24689-121) , manufacture(24689-121)