Generic Name: ibuprofen
Dosage Form: oral suspension
Topco Ibuprofen Oral Suspension Drug Facts
Active ingredient (in each 1.25 mL)
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
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 the 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
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 any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- the stomach bleeding warning applies to your child
- child has a history of stomach problems, such as heartburn
- 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, or kidney disease
- 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
When using this product
- give with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- 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
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)
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- do not give longer than 10 days, unless directed by a doctor (see Warnings)
- 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 day
| Dosing Chart | ||
| Weight (lb) | 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 |
Other information
- do not use if printed neckband is broken or missing
- store at 20-25°C (68-77°F)
- see bottom of box for lot number and expiration date
Inactive ingredients
anhydrous citric acid, butylparaben, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Questions or comments?
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For Ages 6 Mos. to 23 Mos.
Concentrated Drops
Infants’
Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Lasts up to 8 hours
Non-Staining
Alcohol Free
Dye-Free
Berry Flavor
Use Only with Enclosed Syringe
Compare to Motrin® Infants’ Drops Dye-Free active ingredient
Ibuprofen Oral Suspension Carton
| TOPCARE IBUPROFEN ibuprofen suspension/ drops | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075217 | 09/10/2004 | |
| Labeler - Topco Associates LLC (006935977) |
More Topcare Ibuprofen Drops resources
- Topcare Ibuprofen Drops Side Effects (in more detail)
- Topcare Ibuprofen Drops Use in Pregnancy & Breastfeeding
- Drug Images
- Topcare Ibuprofen Drops Drug Interactions
- Topcare Ibuprofen Drops Support Group
- 51 Reviews for Topcare Ibuprofen - Add your own review/rating
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