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

Sunmark ibuprofen

McKesson

  • 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
McKesson Children’s Ibuprofen Oral Suspension Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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.

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

  • •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

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)

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 (lbs)

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 1/2 tsp or 7.5 mL

48-59 lbs

6-8 years

2 tsp or 10 mL

60-71 lbs

9-10 years

2 1/2 tsp or 12.5 mL

72-95 lbs

11 years

3 tsp or 15 mL

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)
  • •do not freeze
  • •see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial bubblegum flavors, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO CHILDREN'S MOTRIN® BUBBLE GUM FLAVOR ACTIVE INGREDIENT

Children’s ibuprofen oral suspension

100 mg per 5 mL (teaspoonful)

Pain reliever, Fever reducer (NSAID)

For ages 2 to 11

Lasts up to 8 hours

Alcohol free

BUBBLE GUM FLAVOR

GLUTEN FREE

Sunmark ibuprofen

Ibuprofen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-500
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
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
HYPROMELLOSES
polysorbate 80
water
SODIUM BENZOATE
sorbitol
XANTHAN GUM

Product Characteristics

Color
PINK (light)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:49348-500-34 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074937 2003-06-24


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Be sure to consult your doctor before taking any medication!
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