Midol® Liquid Gels

Midol (Ibuprofen) Bayer, capsule, liquid filled (200 mg)

Active Ingredient(s):

Ibuprofen

Country:

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Off On

PurposesCollapse

Pain reliever/fever reducer

UsesCollapse

  • 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

DirectionsCollapse

  • 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

WarningsCollapse

Allergy AlertCollapse

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 WarningCollapse

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

OTC - Do Not Use SectionCollapse

Do not use

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

OTC - Ask Doctor SectionCollapse

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

OTC - Ask Doctor/pharmacist SectionCollapse

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

OTC - When Using SectionCollapse

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

OTC - Stop Use SectionCollapse

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

OTC - Pregnancy Or Breast Feeding SectionCollapse

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.

OTC - Keep Out Of Reach Of Children SectionCollapse

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

Principal Display Panel - 200 Mg Capsule CartonCollapse

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

Principal Display Panel - 200 mg Capsule Carton
MIDOL 
ibuprofen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-8080
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII: WK2XYI10QM) Ibuprofen 200 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
gelatin (UNII: 2G86QN327L)  
hypromelloses (UNII: 3NXW29V3WO)  
mannitol (UNII: 3OWL53L36A)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
povidone K30 (UNII: U725QWY32X)  
water (UNII: 059QF0KO0R)  
sorbitan (UNII: 6O92ICV9RU)  
sorbitol (UNII: 506T60A25R)  
titanium dioxide (UNII: 15FIX9V2JP)  
alpha-tocopherol (UNII: H4N855PNZ1)  
Product Characteristics
Color TURQUOISE Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code MIDOL
Contains     
Packaging
# Item Code Package Description
1 NDC:0280-8080-20 1 in 1 CARTON
1 20 in 1 BOTTLE
2 NDC:0280-8080-25 1 in 1 CARTON
2 25 in 1 BOTTLE
Marketing Information (Status: active)
Marketing Category Application Number or Monograph Citation Application Approval Date Marketing Start Date
NDA NDA021472 05/18/2009
Labeler - Bayer HealthCare LLC - Consumer Care (785159372)

Collapse All Sections Collapse

SPL Unclassified SectionCollapse

Drug Facts

Active Ingredient (in Each Capsule)Collapse

Ibuprofen 200 mg (NSAID)1


1
nonsteroidal anti-inflammatory drug

PurposesCollapse

Pain reliever/fever reducer

UsesCollapse

  • 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

WarningsCollapse

Allergy AlertCollapse

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 WarningCollapse

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

OTC - Do Not Use SectionCollapse

Do not use

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

OTC - Ask Doctor SectionCollapse

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

OTC - Ask Doctor/pharmacist SectionCollapse

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

OTC - When Using SectionCollapse

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

OTC - Stop Use SectionCollapse

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

OTC - Pregnancy Or Breast Feeding SectionCollapse

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.

OTC - Keep Out Of Reach Of Children SectionCollapse

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

DirectionsCollapse

  • 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 InformationCollapse

  • 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 IngredientsCollapse

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

Questions?Collapse

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

SPL Unclassified SectionCollapse

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

Principal Display Panel - 200 Mg Capsule CartonCollapse

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

Principal Display Panel - 200 mg Capsule Carton
MIDOL 
ibuprofen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-8080
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII: WK2XYI10QM) Ibuprofen 200 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
gelatin (UNII: 2G86QN327L)  
hypromelloses (UNII: 3NXW29V3WO)  
mannitol (UNII: 3OWL53L36A)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
povidone K30 (UNII: U725QWY32X)  
water (UNII: 059QF0KO0R)  
sorbitan (UNII: 6O92ICV9RU)  
sorbitol (UNII: 506T60A25R)  
titanium dioxide (UNII: 15FIX9V2JP)  
alpha-tocopherol (UNII: H4N855PNZ1)  
Product Characteristics
Color TURQUOISE Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code MIDOL
Contains     
Packaging
# Item Code Package Description
1 NDC:0280-8080-20 1 in 1 CARTON
1 20 in 1 BOTTLE
2 NDC:0280-8080-25 1 in 1 CARTON
2 25 in 1 BOTTLE
Marketing Information (Status: active)
Marketing Category Application Number or Monograph Citation Application Approval Date Marketing Start Date
NDA NDA021472 05/18/2009
Labeler - Bayer HealthCare LLC - Consumer Care (785159372)

Revised: 10/2011
 
Bayer HealthCare LLC - Consumer Care