Maximum Strength Menstrual Complete description, usages, side effects, indications, overdosage, supplying and lots more!

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Maximum Strength Menstrual Complete

Cardinal Health

Leader 44-390


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Stimulant
Diuretic

Maximum Strength Menstrual Complete Uses

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

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 caplets in 24 hours, which is the maximum daily ammount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinnks 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, aska  doctor or pharmacist.

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
  • alcohol, sedatives and tranquilizers may increase
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • 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 appear
  • redness or swelling is present
  • pain gets worse or lasts more than 10 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 reocmmended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.

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 8 caplets in 24 hours.
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Maximum Strength Menstrual Complete Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

cellulose, croscarmellose sodium, hypromellose, magnesium stearate, poludextrose, polyethylene glycol, silica gel, stearic acid, titanium dioxide, triacetin

Principal Display Panel

NDC 37205-738-62

LEADER®

Compare to Midol® Complete active ingredients*

MAXIMUM STRENGTH
Menstrual Complete
Acetaminophen
, Caffeine, Pyrliamine maleate
Pain Reliever • Stimulant • Diuretic
Multi-Symptom Relief
Cramps•Bloating•Fatigue•Backache•Headache

24 CAPLETS

*This product is not manufactured or distributed by Bayer HealthCare, LLC, owner of the registered trademark Midol® Complete.
50844    ORG061239008

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

Maximum Strength Menstrual Complete
Leader 44-390

Maximum Strength Menstrual Complete

Acetaminophen, Caffeine and Pyrilamine maleate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-738
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 60 mg
PYRILAMINE MALEATE PYRILAMINE 15 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
STEARIC ACID
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm 44;390 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:37205-738-62 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2002-04-29


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Be sure to consult your doctor before taking any medication!
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