Childrens Ibuprofen — v1

Childrens Ibuprofen

8 Views

Version

v1

Effective date

September 29, 2025

Original packager

Sections captured

17

Identifiers

Document ID
a1a5a9c7-c727-4e41-a8f0-2982f796a3ca
Set ID
a1a5a9c7-c727-4e41-a8f0-2982f796a3ca
Application numbers
ANDA074937
Product NDCs
68788-4031
Package NDCs
68788-4031-1
Original packager NDCs
45802-140

Names & Manufacturers

Brand names
Childrens Ibuprofen
Generic names
IBUPROFEN
Manufacturer names
Preferred Pharmaceuticals Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
IBUPROFEN
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Nonsteroidal Anti-inflammatory Drug [EPC]
Pharmacologic class (CS)
Anti-Inflammatory Agents, Non-Steroidal [CS]
Mechanism of action
Cyclooxygenase Inhibitors [MoA]

Other identifiers

NUI
M0001335, N0000000160, N0000175722
RxCUI
UNII
WK2XYI10QM
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each 5 mL) Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if the child is • under a doctor’s care for any serious condition • taking any other drug
Do Not Use (1)

Sequence 1

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
Dosage And Administration (1)

Sequence 1

Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • mL = milliliter • find right dose on chart. If possible, use weight to dose; otherwise use age. • use only enclosed dosing cup. Do not use any other dosing device. • 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 (lb) Age (yr) Dose (mL)** under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL **or as directed by a doctor
Dosage And Administration Table (1)

Sequence 1

Dosing Chart
Weight (lb)Age (yr)Dose (mL)**
under 24 lbsunder 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL
Inactive Ingredient (1)

Sequence 1

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
Indications And Usage (1)

Sequence 1

Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever
Keep Out Of Reach Of Children (1)

Sequence 1

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)
Package Label Principal Display Panel (1)

Sequence 1

Principal Display Panel Compare to Children’s Motrin ® active ingredient Children’s Ibuprofen Oral Suspension 100 mg per 5mL Pain Reliever/Fever Reducer (NSAID) For Ages 2 to 11 Years • Lasts up to 8 Hours • Alcohol Free • Gluten Free Bubble Gum Flavor 4 FL OZ (118 mL) Relabeled By: Preferred Pharmaceuticals Inc. Padagis ® Childrens Ibuprofen Oral Suspension
Purpose (1)

Sequence 1

Purposes Pain reliever/fever reducer
Questions (1)

Sequence 1

Questions or comments? 1-800-719-9260
Spl Product Data Elements (1)

Sequence 1

Childrens Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP HYPROMELLOSE, UNSPECIFIED POLYSORBATE 80 WATER SODIUM BENZOATE SORBITOL SOLUTION XANTHAN GUM light
Stop Use (1)

Sequence 1

Stop use and ask a doctor if • child experiences any of the following signs of stomach bleeding: o feels faint o vomits blood o has bloody or black stools o has stomach pain that does not get better • child has symptoms of heart problems or stroke: o chest pain o trouble breathing o weakness in one part or side of body o slurred speech o 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
Storage And Handling (1)

Sequence 1

Other information • each 5 mL 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
Warnings (1)

Sequence 1

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 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: o feels faint o vomits blood o has bloody or black stools o has stomach pain that does not get better • child has symptoms of heart problems or stroke: o chest pain o trouble breathing o weakness in one part or side of body o slurred speech o 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)
When Using (1)

Sequence 1

When using this product • give with food or milk if stomach upset occurs

OpenFDA raw payload

{'application_number': ['ANDA074937'],
 'brand_name': ['Childrens Ibuprofen'],
 'generic_name': ['IBUPROFEN'],
 'manufacturer_name': ['Preferred Pharmaceuticals Inc.'],
 'nui': ['N0000000160', 'M0001335', 'N0000175722'],
 'original_packager_product_ndc': ['45802-140'],
 'package_ndc': ['68788-4031-1'],
 'pharm_class_cs': ['Anti-Inflammatory Agents, Non-Steroidal [CS]'],
 'pharm_class_epc': ['Nonsteroidal Anti-inflammatory Drug [EPC]'],
 'pharm_class_moa': ['Cyclooxygenase Inhibitors [MoA]'],
 'product_ndc': ['68788-4031'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['a1a5a9c7-c727-4e41-a8f0-2982f796a3ca'],
 'spl_set_id': ['a1a5a9c7-c727-4e41-a8f0-2982f796a3ca'],
 'substance_name': ['IBUPROFEN'],
 'unii': ['WK2XYI10QM']}