Infants Ibuprofen Concentrated Drops,Ibuprofen Oral Suspension Drug Facts

Drug Details [pdf]

IBUPROFEN - ibuprofen suspension
Strides Pharma Inc

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Infants Ibuprofen Concentrated Drops,
Ibuprofen Oral Suspension

Drug Facts

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Fever reducer/Pain reliever

Uses

temporarily:

reduces fever
relieves minor aches and pains due to the common cold, flu, headache 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.

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 problems or serious side effects from taking pain relievers or fever reducers
child has a history of stomach problems, such as heartburn
child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
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

take 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
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

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

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.
repeat dose every 6-8 hours, if needed
do not use more than 4 times a day
measure with the dosing device provided. Do not use with any other device.

Dosing Chart
Weight (lb)	Age (mos)	Dose (mL)
under 6 mos		ask a doctor
12-17 lb	6-11 mos	1.25 mL
18-23 lb	12-23 mos	1.875 mL

Other Information

one dose lasts 6-8 hours
store at 20-25°C (68-77°F)
see bottom of box for lot number and expiration date

Inactive ingredients

citric acid monohydrate, edetate disodium dihydrate, glycerin, microcrystalline cellulose, natural and artificial flavors, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol solution, sucrose and xanthan gum

Questions or comments?

Call Strides Pharma Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825 or ask your pharmacist, doctor or health care professional or visit www.strides.com.

Manufactured by:

Strides Pharma Science Limited

Bengaluru - 562106, India.

Distributed by:

Strides Pharma Inc.,

East Brunswick, NJ 08816

Revised: 05/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See New Warnings

NDC: 59556-149-01

For Ages 6-23 Months

Ibuprofen Concentrated Drops

Oral Suspension 50 mg per 5 mL

Pain Reliever / Fever Reducer (NSAID)

Lasts up to

8 hours

Alcohol Free

Mix Berry Flavor

1/2 fl oz (15 mL)