Childrens Ibuprofen description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Ibuprofen

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FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoon)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.

The chances are 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

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.

  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • 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, or kidney disease
  • child is taking a diuretic
  • under a doctor’s care for any serious condition
  • taking any other drug
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • 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
  • the child does not get any relief within the 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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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.
  • Use only enclosed measuring cup
  • If needed, repeat dose every 6-8 hours
  • Do not use more than 4 times a day
  • Replace original bottle cap to maintain child resistance
Dosing Chart
Weight (lb) Age (yr) Dose (tsp or mL)
under 2 years ask a doctor
24 – 35 lbs 2 – 3 years 1 tsp or 5 mL
36 – 47 lbs 4 – 5 years 1½ tsp or 7.5 mL
48 – 59 lbs 6 – 8 years 2 tsp or 10 mL
60 – 71 lbs 9 – 10 years 2½ tsp or 12.5 mL
72 – 95 lbs 11 years 3 tsp or 15 mL

Other information

  • do not use if printed neckband is broken or missing
  • store between 20 - 25°C (68 - 77°F)
  • see bottom panel for lot number and expiration date

Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

Grape flavor: citric acid, D&C red #33, FD&C blue #1, FD&C Red #40, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40,  glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum.

1-800-432-8534 (select option # 2) between 9 am and 4 pm EST, Monday – Friday.

ORIGINAL BERRY FLAVOR

Compare to the active ingredient in Children’s Motrin®*

For ages 2 to 11

CHILDREN’S Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL (teaspoon)

See New Warnings Information

Pain Reliever

Fever Reducer

Lasts up to 8 hours

Original Berry Flavor

Alcohol Free

4 FL OZ (118 mL)

Childrens Ibuprofen
ORIGINAL BERRY FLAVOR CARTON LABEL DYE-FREE BERRY FLAVOR Compare to the active ingredient in Children’s Motrin® Dye-Free Berry*For ages 2 to 11 CHILDREN’S Ibuprofen Oral Suspension, USP (NSAID)100 mg per 5 mL (teaspoon)See New Warnings InformationPain RelieverFever ReducerLasts up to 8 hoursDye-FreeBerry FlavorAlcohol Free4 FL OZ (118 mL) DYE FREE BERRY FLAVOR CARTON LABEL GRAPE FLAVOR Compare to the active ingredient in Children’s Motrin®*For ages 2 to 11 CHILDREN’S Ibuprofen Oral Suspension, USP (NSAID)100 mg per 5 mL (teaspoon)See New Warnings InformationPain RelieverFever ReducerLasts up to 8 hoursGrape FlavorAlcohol Free4 FL OZ (118 mL) GRAPE FLAVOR CARTON LABEL BUBBLE GUM FLAVOR Compare to the active ingredient in Children’s Motrin®*For ages 2 to 11 CHILDREN’S Ibuprofen Oral Suspension, USP (NSAID)100 mg per 5 mL (teaspoon)See New Warnings InformationPain RelieverFever ReducerLasts up to 8 hoursBubble Gum FlavorAlcohol Free4 FL OZ (118 mL) BUBBLE GUM FLAVOR CARTON LABEL

Childrens Ibuprofen

Ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-255
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 100 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
FD&C RED NO. 40
GLYCERIN
HYPROMELLOSES
polysorbate 80
water
SODIUM BENZOATE
SUCROSE
XANTHAN GUM

Product Characteristics

Color
ORANGE (red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:68016-255-94 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074916 2006-06-01


Childrens Ibuprofen

Ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-261
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 100 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
HYPROMELLOSES
polysorbate 80
water
SODIUM BENZOATE
SUCROSE
XANTHAN GUM

Product Characteristics

Color
WHITE (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:68016-261-94 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074916 2006-06-01


Childrens Ibuprofen

Ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-262
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 100 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
HYPROMELLOSES
polysorbate 80
water
SODIUM BENZOATE
SUCROSE
XANTHAN GUM
D&C RED NO. 33
FD&C BLUE NO. 1

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:68016-262-94 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074916 2006-06-01


Childrens Ibuprofen

Ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-263
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 100 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
HYPROMELLOSES
polysorbate 80
water
SODIUM BENZOATE
SUCROSE
XANTHAN GUM

Product Characteristics

Color
PINK (light)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:68016-263-94 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074916 2006-06-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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