Dolex Children Ibuprofen
ac3c264f-da37-a474-e053-2a95a90abdad
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
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Source: dailymed · Ingested: 2026-02-15T11:58:40.100881 · Updated: 2026-03-14T22:58:19.730903