Children’s Ibuprofen Oral Suspension USP
Childrens Ibuprofen by
Drug Labeling and Warnings
Childrens Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc., G&W Industries, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
CHILDRENS IBUPROFEN- ibuprofen suspension
Pharmaceutical Associates, Inc.
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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. 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) | Dose (mL)* |
| under 24 lbs | 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)
Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage form:
NDC: 0121-0917-05: 5 mL unit dose cup
NDC: 0121-0917-00: Case contains 100 unit dose cups of 5 mL (0121-0917-05)
Inactive ingredients
acesulfame potassium, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose, xanthan gum.
Principal Display Panel
Delivers 5 mL
NDC: 0121-0917-05
Children’s Ibuprofen Oral Suspension, USP
(NSAID)
100 mg per 5 mL
Pain Reliever/Fever Reducer
Berry Flavored/Dye Free/Alcohol Free
SHAKE WELL
Package Not Child-Reistant
| CHILDRENS IBUPROFEN
ibuprofen suspension |
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| Labeler - Pharmaceutical Associates, Inc. (044940096) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| G&W Industries, Inc. | 079419931 | manufacture(0121-0917) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmaceutical Associates, Inc. | 097630693 | label(0121-0917) | |