Children's Ibuprofen Oral Suspension, USP
Childrens Ibuprofen Oral Suspension by
Drug Labeling and Warnings
Childrens Ibuprofen Oral Suspension by is a Otc medication manufactured, distributed, or labeled by PAI Holdings, LLC dba PAI Pharma. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
CHILDRENS IBUPROFEN ORAL SUSPENSION- ibuprofen suspension
PAI Holdings, LLC dba PAI Pharma
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Children's Ibuprofen Oral Suspension, USP
Uses
temporarily:
- relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
- reduces fever
Warnings
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.
Do not use
- if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- 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
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
- 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
Directions
- 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 below. 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
| Weight (lb) | Age (yr) | Dose (mL)* |
|---|---|---|
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 72-95 lbs | 11 years | 15 mL |
* or as directed by a doctor
Other information
■ each 5 mL contains: sodium 2 mg
■ store between 20° to 25°C (68° to 77°F)
■ do not use if carton is opened or if safety seal under cap printed with “SEALED FOR YOUR PROTECTION” is torn or missing
Children’s Ibuprofen Oral Suspension is a white to off-white suspension supplied in the following:
NDC: 0121-0833-04: 4 fl oz (120 mL) bottle
NDC: 0121-0833-81: Case contains 12 cartons of NDC: 0121-0833-04.
NDC: 0121-0833-05: 5 mL unit dose cup.
NDC: 0121-0833-00: Case contains 100 unit dose cups of 5 mL packaged in 10 trays of 10 unit dose cups each.
NDC: 0121-0833-40: Case contains 40 unit dose cups of 5 mL packaged in 4 trays of 10 unit dose cups each.
NDC: 0121-1666-10: 10 mL unit dose cup.
NDC: 0121-1666-00: Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.
NDC: 0121-1666-40: Case contains 40 unit dose cups of 10 mL packaged in 4 trays of 10 unit dose cups each.
Inactive ingredients
avicel, citric acid, glycerin, polysorbate 80, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol solution, sucrose, xanthan gum. May contain citric acid and sodium citrate dihydrate for pH adjustment.
PRINCIPAL DISPLAY PANEL
NDC 0121-0833-04
Compare to Children's Motrin® active ingredient**
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
Alcohol Free/Dye Free
4 fl oz (120 mL)
PAI Pharma
| CHILDRENS IBUPROFEN ORAL SUSPENSION
ibuprofen suspension |
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| CHILDRENS IBUPROFEN ORAL SUSPENSION
ibuprofen suspension |
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| Labeler - PAI Holdings, LLC dba PAI Pharma (044940096) |