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Menstrual Complete Maximum Strength

Medically reviewed on November 7, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 60mg, PYRILAMINE MALEATE 15mg
Labeler: CARDINAL HEALTH
NDC Code: 37205-738

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.

Leader 44-390

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses
  • for the temporary relief of these symptoms associated with menstrual periods:
    • bloating
    • headache
    • water-weight gain
    • cramps
    • backache
    • breast tenderness
    • fatigue
    • muscle aches

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • 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
  • difficulty in urination due to enlargement of the prostate gland 
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

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 while taking this product 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

These could be signs of a serious condition. 

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 (see overdose warning)
  • 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: ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Principal Display Panel

NDC 37205-738-62

LEADER®

Compare to
Midol® Complete
active ingredients*

MAXIMUM STRENGTH
M en s t r u a l  C o m p l e t e

Acetaminophen, Caffeine, Pyrilamine maleate
Pain Reliever • Diuretic • Antihistamine

Multi-Symptom Relief
Cramps • Bloating • Fatigue • Backache • Headache

SATISFACTION
GUARANTEED

24 CAPLETS

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
50844       REV0913A39008

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4595625

www.myleader.com        1-800-200-6313

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER  UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Leader 44-390

MENSTRUAL COMPLETE  MAXIMUM STRENGTH
acetaminophen, caffeine and pyrilamine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-738
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
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
MICROCRYSTALLINE CELLULOSE 
CROSPOVIDONE, UNSPECIFIED 
STARCH, CORN 
Product Characteristics
ColorWHITEScorescore with uneven pieces
ShapeOVALSize17mm
FlavorImprint Code44;390
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-738-623 BLISTER PACK in 1 CARTON
18 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/29/2002
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(37205-738)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(37205-738)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(37205-738)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(37205-738)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(37205-738)

 
CARDINAL HEALTH

← See all Menstrual Complete Maximum Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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