Midol Complete description, usages, side effects, indications, overdosage, supplying and lots more!

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Midol Complete

Bayer HealthCare LLC, Consumer Care

Midol Complete


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Caffeine 60 mg Diuretic
Pyrilamine maleate 15 mg Antihistamine

Midol Complete 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

Midol Complete 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 - 40 Caplet Bottle Carton

VALUE SIZE

Midol®
Complete

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

MAXIMUM STRENGTH
MULTI-SYMPTOM
RELIEF OF

CRAMPS, BLOATING
FATIGUE, BACKACHE
& HEADACHE

40 CAPLETS

Midol Complete

Midol Complete

ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-8005
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
carnauba wax
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
propylene glycol
SHELLAC
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm MIDOL OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 40 in 1 BOTTLE
4 NDC:0280-8005-40 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2014-02-10


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Be sure to consult your doctor before taking any medication!
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