MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet 
R J General Corporation

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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.

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.

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.

Other information

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) 

PRINCIPAL DISPLAY PANEL - 100 Caplet Pouch Carton

Midol ®
Complete

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

MAXIMUM STRENGTH
MULTI-SYMPTOM
RELIEF OF

CRAMPS, BLOATING
FATIGUE, BACKACHE
& HEADACHE

50 POUCHES of 2 CAPLETS

image description
MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70264-012(NDC:0280-8005)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TRIACETIN (UNII: XHX3C3X673)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code MIDOL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70264-012-0150 in 1 CARTON10/02/2014
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/10/2014
Labeler - R J General Corporation (122542830)
Establishment
NameAddressID/FEIBusiness Operations
R J General Corporation122542830repack(70264-012)

Revised: 10/2023
Document Id: 07cf3b5b-9d54-6517-e063-6394a90ae43f
Set id: 0c09a178-1a07-4079-b4a6-d1657cb8e714
Version: 5
Effective Time: 20231016
 
R J General Corporation