FDA Label for Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 1.25 ML)
- PURPOSE
- USES
- ALLERGY ALERT
- STOMACH BLEEDING WARNING
- HEART ATTACK AND STROKE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Strides Pharma Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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
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. 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
citric acid monohydrate, edetate disodium dihydrate, glycerin, microcrystalline cellulose, natural and artificial flavors, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol solution, sucrose and xanthan gum
Questions Or Comments?
Call Strides Pharma Inc. Weekdays from 9 AM to 5 PM EST at 1-877-244-9825 or ask your pharmacist, doctor or health care professional or visit www.strides.com.
Manufactured by:
Strides Pharma Science Limited
Bengaluru - 562106, India.
Distributed by:
Strides Pharma Inc.,
East Brunswick, NJ 08816
Revised: 11/2022
Package Label.Principal Display Panel
NDC 59556-118-01
Ibuprofen Concentrated Drops
Oral Suspension 50 mg per 1.25 mL
Pain Reliever / Fever Reducer (NSAID)
Lasts up to
8 hours
Dye- Free
1/2 FL OZ (15 mL)
Alcohol Free
White Mix Berry Flavor
For Ages 6-23 Months
NDC 59556-118-02
Ibuprofen Concentrated Drops
Oral Suspension 50 mg per 1.25 mL
Pain Reliever / Fever Reducer (NSAID)
Lasts up to
8 hours
Dye- Free
1/2 FL OZ (30 mL)
Alcohol Free
White Mix Berry Flavor
For Ages 6-23 Months
NDC 59556-233-01
Ibuprofen Concentrated Drops
Oral Suspension 50 mg per 1.25 mL
Pain Reliever / Fever Reducer (NSAID)
Lasts up to
8 hours
Dye- Free
1/2 FL OZ (15 mL)
Alcohol Free
Grape Flavored Drops
For Ages 6-23 Months
NDC 59556-233-02
Ibuprofen Concentrated Drops
Oral Suspension 50 mg per 1.25 mL
Pain Reliever / Fever Reducer (NSAID)
Lasts up to
8 hours
Dye- Free
1/2 FL OZ (15 mL)
Alcohol Free
Grape Flavored Drops
For Ages 6-23 Months
* Please review the disclaimer below.
