IBUPROFEN by Strides Pharma Inc IBUPROFEN suspension

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, 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 the 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 the 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,asthma, 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

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: 11/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 59556-118-01

Ibuprofen Concentrated Drops

Oral Suspension 50 mg per 1.25 mL

Pain Reliever / Fever Reducer (NSAID)

Lasts up to

8 hours

Dye- Free

1/2 FL OZ (15 mL)

Alcohol Free

White Mix Berry Flavor

For Ages 6-23 Months

NDC: 59556-118-02

Ibuprofen Concentrated Drops

Oral Suspension 50 mg per 1.25 mL

Pain Reliever / Fever Reducer (NSAID)

Lasts up to

8 hours

Dye- Free

1/2 FL OZ (30 mL)

Alcohol Free

White Mix Berry Flavor

For Ages 6-23 Months

NDC: 59556-233-01

Ibuprofen Concentrated Drops

Oral Suspension 50 mg per 1.25 mL

Pain Reliever / Fever Reducer (NSAID)

Lasts up to

8 hours

Dye- Free

1/2 FL OZ (15 mL)

Alcohol Free

Grape Flavored Drops

For Ages 6-23 Months

NDC: 59556-233-02

Ibuprofen Concentrated Drops

Oral Suspension 50 mg per 1.25 mL

Pain Reliever / Fever Reducer (NSAID)

Lasts up to

8 hours

Dye- Free

1/2 FL OZ (15 mL)

Alcohol Free

Grape Flavored Drops

For Ages 6-23 Months

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-118
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	50 mg  in 1.25 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-118-01	1 in 1 CARTON	04/04/2025
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 59556-118-02	1 in 1 CARTON	04/04/2025
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214071	04/04/2025

IBUPROFEN 
ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-233
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	50 mg  in 1.25 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-233-01	1 in 1 CARTON	04/04/2025
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 59556-233-02	1 in 1 CARTON	04/04/2025
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214071	04/04/2025

Labeler - Strides Pharma Inc (078868278)