Label: MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet tablet

  • NDC Code(s): 29485-2802-2, 29485-7358-4, 29485-7964-2, 29485-7964-3, view more
    29485-7964-4
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 20, 2023

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  • Drug Facts

    Drug Facts

  • 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

    Liver warning

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

    • more than 6 caplets 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 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 more than 10 days
    • fever gets worse or lasts more than 3 days

    If pregnant 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

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

    store at room temperature

  • INACTIVE INGREDIENTS

    carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

  • QUESTIONS OR COMMENTS?

    1-800-331-4536 (Mon-Fri 9AM-5PM EST) or www.midol.com

  • Active Ingredient

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain reliever
    Caffeine 60 mgDiuretic
    Pyrilamine maleate 15 mgAntihistamine

  • PRINCIPAL DISPLAY PANEL- 2 Caplet Pouch Package

    Midol ®
    COMPLETE

    Acetaminophen/Caffeine/Pyrilamine Maleate
    Pain Reliever/Diuretic/Antihistamine

    BAYER

    MULTI-SYMPTOM RELIEF OF

    CRAMPS • BLOATING • FATIGUE

    HEADACHE • BACKACHE

    2
    Caplets

    Midol 2ct

  • PRINCIPAL DISPLAY PANEL-4 Caplet Pouch Package

    Midol ®
    COMPLETE

    Acetaminophen/Caffeine/Pyrilamine Maleate
    Pain Reliever/Diuretic/Antihistamine

    BAYER

    MULTI-SYMPTOM RELIEF OF

    CRAMPS • BLOATING • FATIGUE

    HEADACHE • BACKACHE

    4
    Caplets

    Midol 4ct

  • PRINCIPAL DISPLAY PANEL-25 Caplet Pouch Box

    Midol ®
    COMPLETE

    Acetaminophen/Caffeine/Pyrilamine Maleate
    Pain Reliever/Diuretic/Antihistamine

    BAYER

    MULTI-SYMPTOM RELIEF OF

    CRAMPS • BLOATING • FATIGUE

    HEADACHE • BACKACHE

    25 POUCHES 2 CAPLETS EACH

    Midol 25ct

  • PRINCIPAL DISPLAY PANEL-30 Caplet Pouch Box

    Midol ®
    COMPLETE

    Acetaminophen/Caffeine/Pyrilamine Maleate
    Pain Reliever/Diuretic/Antihistamine

    BAYER

    MULTI-SYMPTOM RELIEF OF

    CRAMPS • BLOATING • FATIGUE

    HEADACHE • BACKACHE

    30 POUCHES 2 CAPLETS EACH
    Midol 30ct

  • INGREDIENTS AND APPEARANCE
    MIDOL COMPLETE 
    acetaminophen, caffeine, and pyrilamine maleate tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7358
    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
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    TRIACETIN (UNII: XHX3C3X673)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code Midol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7358-42 in 1 BLISTER PACK05/07/201312/31/2024
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01305/07/201312/31/2024
    MIDOL COMPLETE 
    acetaminophen, caffeine, and pyrilamine maleate tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-2802
    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
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIACETIN (UNII: XHX3C3X673)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code Midol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-2802-21 in 1 BLISTER PACK06/29/200512/31/2024
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01306/29/200512/31/2024
    MIDOL COMPLETE 
    acetaminophen, caffeine, and pyrilamine maleate tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7964
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SHELLAC (UNII: 46N107B71O)  
    TRIACETIN (UNII: XHX3C3X673)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code Midol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7964-225 in 1 BOX07/10/2020
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:29485-7964-330 in 1 BOX10/19/2015
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:29485-7964-450 in 1 BOX07/10/2020
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/19/2015
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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