PediaCare Childrens
Dosage form: liquid
Ingredients: IBUPROFEN 100mg in 5mL
Labeler: Medtech Products Inc.
NDC Code: 63029-911
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
(in each 5 mL = 1 teaspoon)
Ibuprofen, USP 100 mg (NSAID)*
Pain reliever/ fever reducer
*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
- asthma (wheezing)
- skin reddening
- facial swelling
- shock
- rash
- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.
The chances are 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
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 to administer to children under 3 years of age unless directed by doctor.
- if the child has ever had an allergic reaction to 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 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 is taking a diuretic
- under a doctor’s care for any serious condition
- taking any other drug
- take 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
- child experiences any of the following signs of stomach bleeding
- feels faint
- vomits blood
- has bloody or black stools
- feels faint
- has stomach pain that does not get better
- the child does not get any relief within the 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 (1-800-222-1222) right away.
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This product does not contain directions or complete warnings for adult use
-
Do not give more than directed
- Shake well before using
- Find right does on chart below. If possible, use weight to dose; otherwise use age.
- Use only enclosed measuring cup
- 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 (tsp or mL) |
| Under 2 years | ask a doctor | |
| 24-35 lbs | 2-3 years | 1 tsp or 5 mL |
| 36-47 lbs | 4-5 years | 1 ½ tsp or 7.5 mL |
| 48-59 lbs | 6-8 years | 2 tsp or 10 mL |
| 60-71 lbs | 9-10 years | 2 ½ tsp or 12.5 mL |
| 72-95 lbs | 11 years | 3 tsp or 15 mL |
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do not use if printed neckband is broken or missing
- store between 20-25ºC (68-77ºF)
- see bottom panel for lot number and expiration date
citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum
1-888-474-3099 Mon. – Fri. 8:00am to 8:00pm EST or visit us at www.PediaCare.com
NEW! CHILDREN Ages 2-11
PediaCare® we care for kidsTM
PAIN RELIEVER
FEVER REDUCER
IB Ibuprofen
Oral Suspension, USP
(NSAID)
100 mg/ 5 mL
teaspoon
Dye-Free Berry FLAVOR
Lasts up to 8 hours!
4 FL OZ (118 mL)
| PEDIACARE CHILDRENS
ibuprofen liquid |
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| Labeler - Medtech Products Inc. (122715688) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Actavis Mid Atlantic LLC | 809515898 | MANUFACTURE | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
