Rexall Ibuprofen

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Rexall Ibuprofen Recall

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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:

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 your child:

has had stomach ulcers or bleeding problems
takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs [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.

Do not use

if the child has ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if

child has problems or serious side effects from taking pain relievers or fever reducers
stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
child has asthma
child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

under a doctor’s care for any serious condition
taking any other drug

When using this product

mouth or throat burning may occur; give with food or water
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

child experiences any of the following signs of stomach bleeding:
feels faint
vomits blood
has bloody or black stools
has stomach pain that does not get better
the child does not get any relief within the 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

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 the child has ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if

child has problems or serious side effects from taking pain relievers or fever reducers
stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
child has asthma
child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

under a doctor’s care for any serious condition
taking any other drug

Stop use and ask a doctor if

child experiences any of the following signs of stomach bleeding:
feels faint
vomits blood
has bloody or black stools
has stomach pain that does not get better
the child does not get any relief within the 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

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

temporarily:

reduces fever
relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Rexall Ibuprofen Manufacturers

Dolgencorp, Llc

Rexall Ibuprofen | Dolgencorp, Llc

this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3

No Recall
Dolgencorp, Llc

Rexall Ibuprofen | Dolgencorp, Llc

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

No Recall
Dolgencorp Inc

Rexall Ibuprofen | Dolgencorp Inc

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

No Recall
Dolgencorp Inc

Rexall Ibuprofen | Dolgencorp Inc

• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart. If possible, use weight to dose; otherwise use age. • use only 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 (lbs)

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 1/2 tsp or 7.5 mL

48-59 lbs

6-8 years

2 tsp or 10 mL

60-71 lbs

9-10 years

2 1/2 tsp or 12.5 mL

72-95 lbs

11 years
3 tsp or 15 mL

No Recall
Dolgencorp, Llc

Rexall Ibuprofen | Dolgencorp, Llc

• do not take more than directed • the smallest effective dose should be used
Adults and children 12 years and older:
• take 1 tablet every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 tablet, 2 tablets may be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor
Children under 12 years: ask a doctor

No Recall