Dolex Children Ibuprofen

Dolex Children Ibuprofen
SPL v1
SPL
SPL Set ID ac3c264f-da37-a474-e053-2a95a90abdad
Route
ORAL
Published
Effective Date 2020-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Sucrose Acesulfame Potassium Anhydrous Citric Acid D&c Yellow No. 10 Carboxymethylcellulose Sodium Xanthan Gum Cellulose, Microcrystalline Water Polysorbate 80 Propylene Glycol Sodium Benzoate Glycerin Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-08-07

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Section 55105-1
Active ingredient (in each 5 mL)

Purpose

Ibuprofen 100 mg (NSAID)*.......................................................

Pain reliever / fever reducer
*nonsteroidal anti-inflammatory

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6-8 hours not use more than 4 times a day
  • replace original bottle cap to maintain child resistance

Weight (lb) Age (yr) Dose (mL)*
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5
48-59 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL

*or as directed by a doctor

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

Drug Facts

Allergy Alert:

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.

Other Information
  • each 5 mL contains : sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or printed bottle neckband is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium, benzoate, sucrose, and xanthan gum

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.

Questions Or Comments?

Call 732-314-4550 from 9 AM to 5 PM EST, Monday – Friday

When Using This Product
  • take with food or milk if stomach upset occurs
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
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)

Package Principal Display Panel

Heart Attack and Stroke Warning:

NSAIDs, exceptaspirin, 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.

Ask A Doctor Or Pharmacist Before Use If the Child Is
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Uses

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Section 55105-1 (55105-1)
Active ingredient (in each 5 mL)

Purpose

Ibuprofen 100 mg (NSAID)*.......................................................

Pain reliever / fever reducer
*nonsteroidal anti-inflammatory

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6-8 hours not use more than 4 times a day
  • replace original bottle cap to maintain child resistance

Weight (lb) Age (yr) Dose (mL)*
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5
48-59 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL

*or as directed by a doctor

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

Drug Facts

Allergy Alert:

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.

Other Information (Other information)
  • each 5 mL contains : sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or printed bottle neckband is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium, benzoate, sucrose, and xanthan gum

Sore Throat Warning: (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.

Questions Or Comments? (Questions or comments?)

Call 732-314-4550 from 9 AM to 5 PM EST, Monday – Friday

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning: (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
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)

Package Principal Display Panel (PACKAGE PRINCIPAL DISPLAY PANEL)

Heart Attack and Stroke Warning: (Heart attack and stroke warning:)

NSAIDs, exceptaspirin, 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.

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

Advanced Ingredient Data


Raw Label Data

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