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

ibuprofen

CVS Pharmacy

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
CVS Pharmacy, Inc. Junior Strength Ibuprofen Tablets Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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

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.

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

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, or kidney disease
  • •child has asthma
  • •child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

  • •under a doctor’s care for any serious condition
  • •taking any other drug

When using this product

  • •mouth or throat burning may occur; give with food or water
  • •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

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 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

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)

Directions

  • •this product does not contain directions or complete warnings for adult use
  • •do not give more than directed
  • •find the right dose on chart below. If possible, use weight to dose; otherwise use age.
  • •if needed, repeat dose every 6-8 hours
  • •do not use more than 4 times a day

Dosing Chart

Weight (lb)

Age (yr)

Tablets

under 24

under 2

ask a doctor

24-35

2-3

1

36-47

4-5

1 ½

48-59

6-8

2

60-71

9-10

2 ½

72-95

11

3

Other information

  • •phenylketonurics: contains phenylalanine 6 mg per tablet
  • •do not use if printed seal under cap is broken or missing
  • •store at 20-25°C (68-77°F)
  • •see end panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, ammonium glycerrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, prosweet, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Motrin® Junior Strength

FOR AGES 2-11

JUNIOR STRENGTH IBUPROFEN TABLETS

IBUPROFEN TABLETS, 100 mg

Pain reliever / Fever reducer (NSAID)

Lasts up to 8 HOURS

24 Orange flavored Chewable tablets

ibuprofen

Ibuprofen TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-001
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
ASPARTAME
carnauba wax
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
mannitol
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SOYBEAN OIL
SUCCINIC ACID
ACESULFAME POTASSIUM

Product Characteristics

Color Size Imprint Code Shape
ORANGE 13 mm L461 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE
2 NDC:59779-001-62 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076359 2004-05-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.