Ibuprofen Oral Suspension USP, 100 mg/5 mL

Alcohol Free - Grape, Bubblegum and Dye Free Berry Flavours
National Brand Equivalent (NBE) - Motrin Children's Suspension®

DIN Number:
02295970
 
Expiry Date:
2 years from date of manufacture
 

Non-Medicinal Ingredients:

Grape: Artificial Grape Flavour, Carboxymethyl-cellulose Sodium, Citric Acid, EDTA, FD&C Blue No. 1, FD&C Red No. 40, Glycerin, Sorbitol Solution, Microcrystalline Cellulose, Polysorbate 80, Purified Water, Sodium Benzoate and Sucrose.

Bubblegum: Carboxymethylcellulose Sodium, Citric Acid, EDTA, FD&C Red No. 40, Flavour, Glycerin, Sorbitol Solution, Microcrystalline Cellulose, Polysorbate 80, Purified Water, Sodium Benzoate and Sucrose.

Dye Free Berry: Carboxymethylcellulose Sodium, Citric Acid, EDTA, Flavour, Glycerin, Sorbitol Solution, Microcrystalline Cellulose, Polysorbate 80, Purified Water, Sodium Benzoate and Sucrose.

 
Appearance/Sensory:
Grape: Purple coloured suspension, grape flavour and aroma
Bubblegum: Pink coloured suspension, bubblegum flavour and aroma
Dye Free Berry: Clear suspension, berry flavour and aroma
 
Capsule Weight:
1590 to 1750mg
 
Packaging:
120ml Bottle: 120ML white, translucent HDPE round
Cap: white PP CR, induction seal liner
Safety Seal: circular 3.175mm around
Label: 132 mm x 50.8 mm
Carton: 60 mm x 60 mm x 140 mm
Patient information insert: folded: 40 mm x 120 mm
Dosing cup: 1 Fluid Oz
 
Storage:
Store at room temperature between 15-30°C (59-86°F). Keep this and all medication out of the reach of children. Child Resistant Package
 

Directions:

Shake suspension well before use. Use only the enclosed measuring cup or a measured teaspoon to dose this product. Do not use any other dosing device. Measure dose with the dosage cup provided and ensure the complete dose is taken.

For accurate dosing, follow the instructions carefully. Find the right dose on the chart. If possible, use weight to dose, otherwise use age.

Weight
Age
Single Oral Dose
Lbs
Kg
Years
mL
tsp
24-35
11-15.9
2-3
5
1
36-47
16-21.9
4-5
7.5
1.5
48-59
22-26.9
6-8
10
2
60-71
27-31.9
9-10
12.5
2.5
72-95
32-43.9
11
15
3

Single dose may be repeated every 6 to 8 hours as needed. Do not exceed 4 doses of ibuprofen per day unless advised by a doctor.

Do not use for more than 3 days for fever or 5 days for pain unless directed by a doctor. While uncommon, if stomach upset occurs, ibuprofen oral suspension can be given with food or milk. If stomach upset persists, talk to your doctor.

 
Cautions:
Do not give to children who are taking ibuprofen or acetylsalicylic acid (ASA) or who have had an allergic reaction (facial swelling, hives, difficulty breathing or shock) to ASA, other salicylates or other anti-inflammatory drugs. Keep out of the reach or children. If your child is dehydrated (significant fluid loss) due to continued vomiting, diarrhea or lack of fluid intake, talk to our doctor before use. If your child has asthma, is under a doctor's care for any other serious condition or is taking any other drug, talk to your doctor before use. Do not use for more than 3 days for fever or pain unless directed by a doctor. Read Consumer Information for important information before use.
 
Drug Interactions:
Talk to your doctor if your child is taking coumarin-type anticoagulants, diuretics (water tablets), digoxin, metho-trexate, phenytoin, lithium salt, as some drug interaction could occur.
 

Contraindications:

BEFORE giving ibuprofen oral suspension to your child, talk to your doctor or pharmacist if:

  • your child is dehydrated (significant fluid loss) due to continued vomiting, diarrhea or lack of fluid intake
  • your child is suffering from stomach pain
  • your child has peptic ulcers, high blood pressure, heart failure, serious kidney or liver disease, asthma, or is under a doctor’s care for any other serious condition or is taking any other drug
  • your child has a history of gastrointestinal disease, blood clotting problems or taking an anticoagulant

Also, see your doctor if:

  • your child does not get any relief within 24 hours
  • redness or swelling is present in the painful area
  • a sore throat is severe, lasts for more than 2 days or occurs with fever, headache, rash, nausea or vomiting
  • your child develops any vision problems (blurred or reduced vision, colour changes)
  • any new symptoms appear
 
Symptoms and Treatment of Overdose:
In case of accidental overdose, even if there are no symptoms, call a doctor or Poison Control centre at once.
photo not
available
 

Toxicity/Adverse Reactions:

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately:

  • skin rash or itching, dizziness, any change in vision, ringing or buzzing in the ears, nausea or vomiting, abdominal pain or cramps, diarrhea or constipation, heartburn, bloating, fluid retention, indigestion, headache, decreased appetite.

Serious Side Effects

How Often They Happen and What To Do About Them

 
 
Talk with your doctor/pharmacist
 
Symptom/Effect
Only if severe
In all cases
Common
Dizziness
 
X
Uncommon
Blurred/ reduced vision
 
X
Uncommon
Vision colour changes
 
X
Uncommon
Ringing in ears
 
X
Uncommon
Blood in urine or stool
 
X
Uncommon
Swelling of mouth, throat and extremities
 
X
Uncommon
Difficulty breathing
 
X
Uncommon
Abdominal pain
X
 
Uncommon
Severe skin rash
 
X
Uncommon
Weight gain / fluid retention
X
 
Uncommon
Bruising
X
 
 

Product Notes:

Grape


This Product Contains:
Yes
No
Preservatives
X
 
Artificial Colour
X
 
Artificial Flavour
X
 
Gluten
 
X
Yeast
 
X
Starch
 
X
Sugar
X
 
Tartrazine
 
X
Shellfish Derivatives
 
X

 


May be used by a person on a:
Yes
No
Sugar Free Diet
 
X
Milk Free Diet
X
 
Sodium Reduced Diet
X
 
Vegetarian Diet
X
 
Kosher Diet
X
 

* (Sodium presents at low concentration, check with physician)

 

Bubblegum


This Product Contains:
Yes
No
Preservatives
X
 
Artificial Colour
X
 
Artificial Flavour
X
 
Gluten
 
X
Yeast
 
X
Starch
 
X
Sugar
X
 
Tartrazine
 
X
Shellfish Derivatives
 
X

 


May be used by a person on a:
Yes
No
Sugar Free Diet
 
X
Milk Free Diet
X
 
Sodium Reduced Diet
X
 
Vegetarian Diet
X
 
Kosher Diet
X
 

* (Sodium presents at low concentration, check with physician)

 

Dye-Free Berry


This Product Contains:
Yes
No
Preservatives
X
 
Artificial Colour
 
X
Artificial Flavour
X
 
Gluten
 
X
Yeast
 
X
Starch
 
X
Sugar
X
 
Tartrazine
 
X
Shellfish Derivatives
 
X

 


May be used by a person on a:
Yes
No
Sugar Free Diet
 
X
Milk Free Diet
X
 
Sodium Reduced Diet
X
 
Vegetarian Diet
X
 
Kosher Diet
X
 

* (Sodium presents at low concentration, check with physician)