Active Ingredient (In Each 1.25 Ml)
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Infants Ibuprofen Suspension
FDA Label NDC 0363-5100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Infants Ibuprofen (NDC 0363-5100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 1.25 ml), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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
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:
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 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
When Using This Product
- take with food or milk if stomach upset occurs
Stop Use And Ask A Doctor If
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
- 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
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
- 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 to 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 to 17 lbs | 6 to 11 mos | 1.25 mL |
| 18 to 23 lbs | 12 to 23 mos | 1.875 mL |
Other Information
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Motrin® Infants' Drops active ingredient††
infants'
Dye-Free
Ibuprofen
CONCENTRATED IBUPROFEN
ORAL SUSPENSION, USP (NSAIS)
50 mg PER 1.25 mL
PAIN RELIEVER / FEVER REDUCER
DYE FREE
LASTS UP TO 8 HOURS
ALCOHOL FREE
- Non-staining
- No high fructose corn syrup
AGES 6 -23 MONTHS
BERRY FLAVOR
Use only with enclosed syringe
FL OZ (mL)
††This product is not affiliated with, manufactured by, or produced by the makers or owners of Motrin®.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED FOIL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Package Label
WALGREENS Infants' Dye-Free Ibuprofen
* Please review the disclaimer below.
