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MIDOL COMPLETE by R J General Corporation

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 60mg, PYRILAMINE MALEATE 15mg
Labeler: R J General Corporation
NDC Code: 70264-012

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.

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:

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

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

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
  • 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

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

MIDOL COMPLETE 
acetaminophen, caffeine, and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70264-012(NDC:0280-8005)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE60 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
TRIACETIN 
CARNAUBA WAX 
TITANIUM DIOXIDE 
CROSCARMELLOSE SODIUM 
SHELLAC 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint CodeMIDOL
Contains    
Packaging
#Item CodePackage Description
1NDC:70264-012-0150 POUCH in 1 CARTON
12 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/10/2014
Labeler - R J General Corporation (122542830)
Establishment
NameAddressID/FEIOperations
R J General Corporation122542830REPACK(70264-012)

 
R J General Corporation

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Medically reviewed on Aug 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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