FDA records indicate that there are no current recalls for this drug.
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Leader Ibuprofen Recall
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Questions & Answers
Side Effects & Adverse Reactions
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
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 this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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 these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Leader Ibuprofen Manufacturers
- Cardinal Health
Leader Ibuprofen | H E B
use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor - Cardinal Health
Leader Ibuprofen | Cardinal Health
• do not take more than directed • the smallest effective dose should be usedadults 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 doctorchildren under 12 years
• ask a doctor - Cardinal Health
Leader Ibuprofen | Cardinal Health
do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) 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 - Cardinal Health
Leader Ibuprofen | Cardinal Health
do not take more than directed the smallest effective dose should be used - Cardinal Health
Leader Ibuprofen | Cardinal Health
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 - Cardinal Health
Leader Ibuprofen | Cardinal Health
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 - Cardinal Health
Leader Ibuprofen | Cardinal Health
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 - Cardinal Health
Leader Ibuprofen | Cardinal Health
• 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 below. If possible, use weight to dose; otherwise use age. • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose every 6-8 hours • do not use more than 4 times a dayDosing Chart
Weight (lbs)
Age (mos)
Dose (mL)
under 6 mos
ask a doctor
12-17 lbs
6-11 mos
1.25 mL
18-23 lbs
12-23 mos
1.875 mL
- Cardinal Health
Leader Ibuprofen | Cardinal Health
do not take more than directed the smallest effective dose should be usedadults 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 - Cardinal Health
Leader Ibuprofen | Cardinal Health
• 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 useDosing 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 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
- Cardinal Health
Leader Ibuprofen | Cardinal Health
• 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 useDosing 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 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
- Cardinal Health
Leader Ibuprofen | Cardinal Health
• 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 useDosing 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 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
- Cardinal Health
Leader Ibuprofen | Cardinal Health
• 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 useDosing 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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