MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet 
Lil' Drug Store Products, Inc

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.

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Midol® Complete

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Caffeine 60 mg Diuretic
Pyrilamine maleate 15 mg Antihistamine

Uses

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

Warnings

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, 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 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

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 9-5 EST) or www.midol.com

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

Midol®
complete

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

Relieves: Cramps • Fatigue • Bloating

BAYER

4
Caplets

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton
MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9745
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 500 mg
Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 60 mg
Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate 15 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax (UNII: R12CBM0EIZ)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Starch, Corn (UNII: O8232NY3SJ)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Shellac (UNII: 46N107B71O)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Triacetin (UNII: XHX3C3X673)  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code Midol
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66715-9745-2 2 in 1 CARTON 12/01/2011
1 2 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 12/01/2011
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 2/2017
Document Id: dacfeb85-6a11-4c00-9cba-c8f70a98dbd5
Set id: d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca
Version: 2
Effective Time: 20170202
 
Lil' Drug Store Products, Inc