FDA records indicate that there are no current recalls for this drug.
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Major Childrens Ibuprofen Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.
The chance is higher if the child:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
- takes more or for a longer time than directed
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- not been drinking fluids
- lost a lot of fluid due to vomiting or diarrhea
- high blood pressure
- heart or kidney disease
- taken a diuretic
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- under a doctor’s care for any serious condition
- taking any other drug
- give with food or milk if stomach upset occurs
- long term continuous use may increase the risk of heart attack or stroke
- the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
- stomach pain or upset gets worse or lasts
- the child does not get any relief within first day (24 hours) of treatment
- fever or pain gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
In case of overdose, get medical help or contact a Poison Control Center right away.
- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- not been drinking fluids
- lost a lot of fluid due to vomiting or diarrhea
- high blood pressure
- heart or kidney disease
- taken a diuretic
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- under a doctor’s care for any serious condition
- taking any other drug
- the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
- stomach pain or upset gets worse or lasts
- the child does not get any relief within first day (24 hours) of treatment
- fever or pain gets worse or lasts more than 3 days
- 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
temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Major Childrens Ibuprofen Manufacturers
-
Major Pharmaceuticals
Major Childrens Ibuprofen | Major Pharmaceuticals
this product does not contain directions or complete warnings for adult use do not give more than directed do not give longer than 10 days, unless directed by a doctor (see Warnings) shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age. use only with enclosed measuring cup if needed, repeat dose every 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance wash dosage cup after each use Dosing Chart Weight (lb) Age(yrs) Dose (teaspoonful or mL) under 2 years ask a doctor 24-35 lbs 2-3 years 1 tsp or 5 mL 36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL 48-59 lbs 6-8 years 2 tsp or 10 mL 60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL 72-95 lbs 11 years 3 tsp or 15 mL
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