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 mgPain reliever
Caffeine 60 mgDiuretic
Pyrilamine maleate 15 mgAntihistamine

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 9AM-5PM EST) or www.midol.com

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton

Midol®
complete

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

Relieves: Cramps • Fatigue • Bloating

4
Caplets

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton
MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9745
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)  
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
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code Midol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9745-22 in 1 CARTON12/01/2011
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/01/2011
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 1/2020
Document Id: eec92fbf-360a-4236-b573-86299294a73f
Set id: d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca
Version: 4
Effective Time: 20200107
 
Lil' Drug Store Products, Inc