Other
Drug Facts
Infants Advil Suspension/ Drops
FDA Label NDC 0573-0191
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Infants Advil (NDC 0573-0191). 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 other, active ingredient (in each 1.25 ml), purpose, uses, allergy alert, stomach bleeding warning, heart attack and stroke warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 1.25 Ml)
Ibuprofen 50 mg (NSAID)
nonsteroidal anti-inflammatory drug
Purpose
Fever reducer/Pain reliever
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to the common cold, flu, headaches and toothaches
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
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.
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 the child
- child has problems or serious side effects from taking pain relievers or fever reducers
- child has a history of stomach problems, such as heartburn
- child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- child has not been drinking fluids
- child has lost a lot of fluid due to vomiting or diarrhea
- 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
- 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 the body
- slurred speech
- leg swelling
- 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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.
- repeat dose every 6-8 hours, if needed
- do not use more than 4 times a day
- measure with the dosing device provided. Do not use with any other device.
| Weight (lb) | Age (mos) | Dose (mL) |
|---|---|---|
| under 6 mos | ask a doctor | |
| 12-17 lb | 6-11 mos | 1.25 mL |
| 18-23 lb | 12-23 mos | 1.875 mL |
Other Information
- one dose lasts 6-8 hours
- store at 20-25°C (68-77°F)
- see bottom of box for lot number and expiration date
Inactive Ingredients
acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Questions Or Comments?
Call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional
For most recent product information, visit www.Advil.com.
Principal Display Panel - 15 Ml Bottle Label
Infants'
Advil®
Concentrated Drops
Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
White Grape-Flavored Drops
1/2 FL OZ (15 mL)
Principal Display Panel - 15 Ml Bottle Carton
Infants'
Advil®
Concentrated Drops
Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Fever
Aches & Pains
Lasts Up To
8
Hours
Dye-Free
White Grape Flavored Drops
for ages 6–23 months
1/2 FL OZ (15 mL)
Alcohol-Free
Principal Display Panel (15 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Label
Infants'
Advil®
Concentrated Drops
Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
White Grape-Flavored Drops
1 FL OZ (30 mL)
Principal Display Panel - 30 Ml Bottle Carton
VALUE Size
Infants'
Advil®
Concentrated Drops
Ibuprofen Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Fever
Aches & Pains
Lasts Up To
8
Hours
Dye-Free
White Grape Flavored Drops
for ages 6–23 months
1 FL OZ (30 mL)
Alcohol-Free
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