Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts

Major Pharmaceuticals Children's Ibuprofen Oral Suspension Drug Facts
SPL v1
SPL
SPL Set ID d04a5ea0-0acd-4aaf-8d60-a6b08f3c04a8
Route
ORAL
Published
Effective Date 2012-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Butylparaben Glycerin Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sorbitol Xanthan Gum High Fructose Corn Syrup Hypromelloses D&c Yellow No. 10 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
ANDA Active Since 1999-02-07

Description

Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

temporarily:

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

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. 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
  • wash dosage cup after each use
Dosing Chart
Weight (lb) Age(yrs) Dose (teaspoonful 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 1 ½ tsp or 7.5 mL
48-59 lbs 6-8 years 2 tsp or 10 mL
60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL
72-95 lbs 11 years 3 tsp or 15 mL
Do Not Use
  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Other Information
  • each teaspoon contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions Or Comments?



1-800-719-9260



Relabeled by:



H.J. Harkins Company, Inc.



Nipomo, CA 93444



Principal Display Panel

For Ages 2 to 11

Children’s Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever

Fever Reducer (NSAID)

Lasts up to 8 hours

See New Warnings Information

Berry Flavored Liquid

Alcohol Free

Children's

COMPARE TO the active ingredient of CHILDREN'S MOTRIN®

Children's Ibuprofen Oral Suspension Carton Image 1
When Using This Product
  • give 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
Ask A Doctor Before Use If
  • the 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, or kidney disease
  • 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
  • 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).

Active Ingredient (in Each 5 Ml = 1 Teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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
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

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. 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
  • wash dosage cup after each use
Dosing Chart
Weight (lb) Age(yrs) Dose (teaspoonful 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 1 ½ tsp or 7.5 mL
48-59 lbs 6-8 years 2 tsp or 10 mL
60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL
72-95 lbs 11 years 3 tsp or 15 mL
Do Not Use (Do not use)
  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Other Information (Other information)
  • each teaspoon contains: sodium 2 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, artificial mixed berry flavor, D&C yellow #10, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions Or Comments? (Questions or comments?)



1-800-719-9260



Relabeled by:



H.J. Harkins Company, Inc.



Nipomo, CA 93444



Principal Display Panel

For Ages 2 to 11

Children’s Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever

Fever Reducer (NSAID)

Lasts up to 8 hours

See New Warnings Information

Berry Flavored Liquid

Alcohol Free

Children's

COMPARE TO the active ingredient of CHILDREN'S MOTRIN®

Children's Ibuprofen Oral Suspension Carton Image 1
When Using This Product (When using this product)
  • give 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
Ask A Doctor Before Use If (Ask a doctor before use if)
  • the 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, or kidney disease
  • 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
  • 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).

Active Ingredient (in Each 5 Ml = 1 Teaspoonful) (Active ingredient (in each 5 mL = 1 teaspoonful))

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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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