IBUPROFEN CHILDRENS- ibuprofen suspension
Actavis Pharma, Inc.
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(in each 5 mL)
Ibuprofen, USP 100 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
temporarily:
• relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
• reduces fever
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
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 ibuprofen or any other pain reliever/fever reducer
• right before or after heart surgery
• stomach bleeding warning applies to your child
• child has a history of stomach problems, such as heartburn
• child has problems or serious side effects from taking pain relievers or fever reducers
• 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, kidney disease, or had a stroke
• child has asthma
• child is taking a diuretic
• under a doctor’s care for any serious condition
• taking any other drug
• 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
• child has symptoms of heart problems or stroke:
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
• 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. (1-800-222-1222)
• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• mL = milliliter
• find right dose on chart. If possible, use weight to dose; otherwise use age.
• use only enclosed dosing cup. Do not use any other dosing device.
• 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
Dosing Chart | |
---|---|
Age (yr) | Dose (mL)* |
under 2 years | ask a doctor |
2-3 years | 5 mL |
4-5 years | 7.5 mL |
6-8 years | 10 mL |
9-10 years | 12.5 mL |
11 years | 15 mL |
*or as directed by a doctor
• each 5 mL contains: sodium 2 mg
• store between 20° to 25°C (68° to 77°F)
• do not use if printed neckband is broken or missing
• see bottom panel for lot number and expiration date
Original Berry: acesulfame potassium, citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum
Dye-Free Berry: acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum
Bubble Gum: acesulfame potassium, artificial bubble gum flavor, citric acid anhydrous, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum
Blue Raspberry: acesulfame potassium, citric acid anhydrous, FD&C blue #1, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, artificial raspberry flavor, sucrose, xanthan gum
Actavis™
Compare to the active ingredient in Children’s Motrin® Berry†
NDC 0472-1760-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Original Berry Flavor
Alcohol Free
4 FL OZ (118 mL)
Actavis™
Compare to the active ingredient in Children’s Motrin® Dye Free Berry†
NDC 0472-1761-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Non-Staining
Dye-Free Berry Flavor
Alcohol Free
4 FL OZ (118 mL)
Actavis™
Compare to the active ingredient in Children’s Motrin® Bubble Gum†
NDC 0472-1763-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Bubble Gum Flavor
Alcohol Free
4 FL OZ (118 mL)
Actavis™
Compare to the active ingredient in Children’s Motrin®†
NDC 0472-1764-94
See New Warnings
For Ages 2 to 11 years
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Shake Well
Before Using
Blue Raspberry Flavor
Alcohol Free
4 FL OZ (118 mL)
IBUPROFEN
CHILDRENS
ibuprofen suspension |
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CHILDRENS
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CHILDRENS
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CHILDRENS
ibuprofen suspension |
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Labeler - Actavis Pharma, Inc. (119723554) |