Midol

Dosage form: capsule, liquid filled
Ingredients: Ibuprofen 200mg
Labeler: Bayer HealthCare LLC - Consumer Care
NDC Code: 0280-8080

Midol®
Liquid Gels

Drug Facts

Active ingredient (in each capsule)

Ibuprofen 200 mg (NSAID)


nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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

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 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-8080
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C Blue NO. 1 
gelatin 
hypromelloses 
mannitol 
polyethylene glycols 
povidone K30 
water 
sorbitan 
sorbitol 
titanium dioxide 
alpha-tocopherol 
Product Characteristics
ColorTURQUOISEScoreno score
ShapeCAPSULESize25mm
FlavorImprint CodeMIDOL
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-8080-201 BOTTLE (BOTTLE) in 1 CARTON
120 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
2NDC:0280-8080-251 BOTTLE (BOTTLE) in 1 CARTON
225 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02147205/18/2009
Labeler - Bayer HealthCare LLC - Consumer Care (785159372)

Revised: 10/2011
 
Bayer HealthCare LLC - Consumer Care

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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