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Midol

Bayer HealthCare LLC - Consumer Care

Midol Liquid Gels


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Ibuprofen 200 mg (NSAID)nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Midol Uses

  • temporarily relieves minor aches and pains due to:
    • menstrual cramps
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • toothache
    • the common cold
  • temporarily reduces fever

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over:
    • take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years; consult a doctor

Midol Other information

  • store at 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • read all warnings and directions before use. Keep carton.

Inactive ingredients

FD&C Blue #1, gelatin, hypromellose, mannitol, polyethylene glycol, propylene glycol, povidone, purified water, sorbitan, sorbitol, titanium dioxide, vitamin E polyethylene glycol succinate.

Questions?

1-800-331-4536 or www.midol.com

Distributed by:
Bayer HealthCare LLC
Consumer Care
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Carton

Cramps & Body Ache
Relief in a
Liquid Gel

See new warnings information

Bayer HealthCare

Midol ®
Liquid Gels

IBUPROFEN 200mg (NSAID)
PAIN RELIEVER/
FEVER REDUCER

Temporary Relief of
Minor Aches and Pains
due to Cramps, Backache
and Muscle Aches

20
LIQUID FILLED CAPSULES

Midol

Midol

Ibuprofen CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0280-8080
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSES
mannitol
POLYETHYLENE GLYCOLS
POVIDONE K30
water
SORBITAN
sorbitol
titanium dioxide
ALPHA-TOCOPHEROL

Product Characteristics

Color Size Imprint Code Shape
TURQUOISE 25 mm MIDOL CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BOTTLE
2 25 in 1 BOTTLE
3 NDC:0280-8080-25 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021472 2009-05-18


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Be sure to consult your doctor before taking any medication!
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