Ibuprofen Oral Suspension Usp 50 Mg Per 1.25 Ml

Ibuprofen Oral Suspension Usp 50 Mg Per 1.25 Ml
SPL v1
SPL
SPL Set ID 2a48af51-23e2-4fec-a76b-eef1611750f5
Route
ORAL
Published
Effective Date 2024-04-10
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (50 mg)
Inactive Ingredients
Acesulfame Potassium Propylene Glycol Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Hypromellose 2208 (4000 Mpa.s) Noncrystallizing Sorbitol Solution Polysorbate 80 Starch, Potato Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
ANDA Active Since 2024-04-08

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)








Advanced Ingredient Data


Raw Label Data

All Sections (JSON)