FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- unless you have time for a full night’s sleep
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- in children under 12 years of age
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- right before or after heart surgery
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- with any other product containing diphenhydramine, even one used on skin
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- if you have sleeplessness without pain
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- stomach bleeding warning applies to you
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
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- you are taking a diuretic
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- you have a breathing problem such as emphysema or chronic bronchitis
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- you have glaucoma
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- you have trouble urinating due to an enlarged prostate gland
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- taking sedatives or tranquilizers, or any other sleep-aid
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- under a doctor’s care for any continuing medical illness
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- taking any other antihistamines
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- taking any other drug
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- drowsiness will occur
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- avoid alcoholic drinks
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- do not drive a motor vehicle or operate machinery
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- take with food or milk if stomach upset occurs
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- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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- redness or swelling is present in the painful area
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- any new symptoms appear
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. (1-800-222-1222)
Do not use- •
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- •
- unless you have time for a full night’s sleep
- •
- in children under 12 years of age
- •
- right before or after heart surgery
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- if you have sleeplessness without pain
- •
- stomach bleeding warning applies to you
- •
- you have problems or serious side effects from taking pain relievers or fever reducers
- •
- you have a history of stomach problems, such as heartburn
- •
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
- •
- you are taking a diuretic
- •
- you have a breathing problem such as emphysema or chronic bronchitis
- •
- you have glaucoma
- •
- you have trouble urinating due to an enlarged prostate gland
- •
- taking sedatives or tranquilizers, or any other sleep-aid
- •
- under a doctor’s care for any continuing medical illness
- •
- taking any other antihistamines
- •
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- •
- taking any other drug
- •
- 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
- •
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- •
- redness or swelling is present in the painful area
- •
- any new symptoms appear
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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- for relief of occasional sleeplessness when associated with minor aches and pains
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- helps you fall asleep and stay asleep
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Army And Airforce Exchange Ibuprofen Pm Manufacturers
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Army & Air Force Exchange Service
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