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

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Maximum Strength Menstrual Relief

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Healthcare 44-390




FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Pain reliever
Diuretic
Antihistamine

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

 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
  • 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
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • you may get drowsy
  • excitability may occur, especially in children
  • 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.
  • 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. 

 ask a health professional before use.

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.

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

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

Call 1-800-426-9391

HEALTHCARE
NDC 64092-122-16

*Compare to the active ingredients in Midol® Complete

Maximum Strength
Menstrual Relief
Acetaminophen
500 mg
Caffeine 60 mg, Pyrilamine maleate 15 mg

Pain Reliever, Diuretic, Antihistamine

Relief of: Cramps, Headaches, Bloating,
Backaches and Fatigue

Multi-Symptom/Aspirin Free

16 CAPLETS

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
50844    REV0913F39021

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
www.glwholesale.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Maximum Strength Menstrual Relief

Healthcare 44-390-21

Maximum Strength Menstrual Relief

Acetaminophen, Caffeine and Pyrilamine maleate CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64092-122
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 16 in 1 BOTTLE, PLASTIC
2 NDC:64092-122-16 1 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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