Topcare Ibuprofen Drops: Package Insert / Prescribing Info
Package insert / product label
Generic name: ibuprofen
Dosage form: oral suspension
Drug class: Nonsteroidal anti-inflammatory drugs
Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.
Indications and Usage for Topcare Ibuprofen Drops
temporarily:
- •
- reduces fever
- •
- relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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
Topcare Ibuprofen Drops Dosage and Administration
- •
- 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.
- •
- mL = milliliter
- •
- 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 day
Dosing 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 |
Storage and Handling
- •
- store at 20-25°C (68-77°F)
- •
- do not freeze
- •
- do not use if printed neckband is broken or missing
Inactive ingredients
anhydrous citric acid, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Principal Display Panel
TopCare® health
COMPARE TO MOTRIN® INFANTS’ DROPS
DYE-FREE ACTIVE INGREDIENT
FOR AGES 6 MOS. TO 23 MOS.
CONCENTRATED DROPS
infants’ Ibuprofen
ORAL SUSPENSION
50 mg per 1.25 mL
PAIN RELIEVER
FEVER REDUCER (NSAID)
DYE-FREE
Lasts up to 8 HOURS
• Non-Staining
• No High Fructose Corn Syrup
Use only with enclosed syringe.
Ages 6 mos. to 23 mos.
DYE-FREE BERRY FLAVOR
1 FL OZ (30 mL)
| TOPCARE IBUPROFEN
ibuprofen suspension/ drops |
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| Labeler - Topco Associates LLC (006935977) |
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