Ibuprofen Oral Suspension Usp 50 Mg Per 1.25 Ml
2a48af51-23e2-4fec-a76b-eef1611750f5
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each 1.25 mL) Ibuprofen USP 50 mg (NSAID) * * nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Active ingredient (in each 1.25 mL) Ibuprofen USP 50 mg (NSAID) * * nonsteroidal anti-inflammatory drug
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 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.
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.
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)
- do not use if carton is opened or seal under cap is broken or missing
Do Not Use
- if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Drug Facts
Active ingredient (in each 1.25 mL)
Ibuprofen USP 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Inactive Ingredients
acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum
Questions Or Comments?
Call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/19/1993
When Using This Product
- take with food or milk if stomach upset occurs
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
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
- 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)
Ask A Doctor Or Pharmacist Before Use If the Child Is
- under a doctor's care for any serious condition
- taking any other drug
Package Label Principal Display Panel 1 Fl Oz (30 Ml) Container Label
AUROHEALTH
NDC 58602-227-07
For Ages 6 Mos. to 23 Mos.
Concentrated Infants' Drops
Ibuprofen
Oral Suspension,
USP (NSAID)
50 mg per 1.25 mL
Pain Reliever/Fever Reducer
(NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only with enclosed syringe.
Berry Flavor
1 fl oz (30 mL)
Package Label Principal Display Panel 1 Fl Oz (30 Ml) Container Carton Label
AUROHEALTH
NDC 58602-227-07
#Compare to the active ingredient
in Motrin® Infants' Drops
See New Warnings
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
Ibuprofen
Oral
Suspension, USP
(NSAID)
50 mg per 1.25 mL
Pain Reliever/
Fever Reducer
(NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only
with
enclosed
syringe.
Berry Flavor
1 fl oz (30 mL)
Structured Label Content
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purpose
Pain reliever/fever reducer
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 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.
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.
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)
- do not use if carton is opened or seal under cap is broken or missing
Do Not Use (Do not use)
- if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Drug Facts
Active ingredient (in each 1.25 mL)
Ibuprofen USP 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Inactive Ingredients (Inactive ingredients)
acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum
Questions Or Comments? (Questions or comments?)
Call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/19/1993
When Using This Product (When using this product)
- take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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
- 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. (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)
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
- under a doctor's care for any serious condition
- taking any other drug
Package Label Principal Display Panel 1 Fl Oz (30 Ml) Container Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Label)
AUROHEALTH
NDC 58602-227-07
For Ages 6 Mos. to 23 Mos.
Concentrated Infants' Drops
Ibuprofen
Oral Suspension,
USP (NSAID)
50 mg per 1.25 mL
Pain Reliever/Fever Reducer
(NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only with enclosed syringe.
Berry Flavor
1 fl oz (30 mL)
Package Label Principal Display Panel 1 Fl Oz (30 Ml) Container Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Carton Label)
AUROHEALTH
NDC 58602-227-07
#Compare to the active ingredient
in Motrin® Infants' Drops
See New Warnings
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
Ibuprofen
Oral
Suspension, USP
(NSAID)
50 mg per 1.25 mL
Pain Reliever/
Fever Reducer
(NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only
with
enclosed
syringe.
Berry Flavor
1 fl oz (30 mL)
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Raw Label Data
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Source: dailymed · Ingested: 2026-02-15T12:02:58.247751 · Updated: 2026-03-14T23:02:48.423363