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sunmark ibuprofen by McKesson

Medically reviewed on November 14, 2017

Dosage form: suspension/ drops
Ingredients: IBUPROFEN 50mg in 1.25mL
Labeler: McKesson
NDC Code: 49348-642

McKesson Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 ibuprofen or 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, kidney disease, or had a stroke
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

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
child has symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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 below. If possible, use weight to dose; otherwise use age.
mL = milliliter
measure with the dosing device provided. Do not use with any other device.
dispense liquid slowly into the child’s mouth, toward the inner cheek
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day
 
Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

Other information
store at 20-25°C (68-77°F)
do not freeze
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, glycerin, hypromellose, natural and artificial berry flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO MOTRIN® INFANTS’ DROPS

ACTIVE INGREDIENT

See New Warnings

For ages 6 mos. to 23 mos.

Infants’ ibuprofen oral suspension

50 mg per 1.25 mL

Pain reliever

Fever reducer (NSAID)

CONCENTRATED DROPS

Lasts up to 8 hours

Dye-Free

No high fructose corn syrup

Non-Staining

Use only with enclosed syringe.

BERRY FLAVOR

GLUTEN FREE

1 FL OZ (30 mL)

SUNMARK IBUPROFEN 
ibuprofen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-642
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
ANHYDROUS CITRIC ACID 
Product Characteristics
ColorWHITE (Opaque) Score    
ShapeSize
FlavorBERRY (mixed) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-642-271 BOTTLE in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07521704/29/2004
Labeler - McKesson (177667227)

 
McKesson

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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