Hy-vee, Inc. Children’s Ibuprofen Drug Facts

Hy-vee, Inc. Children’s Ibuprofen Drug Facts
SPL v3
SPL
SPL Set ID 2fd51545-1d1f-4b2e-a084-d28ba223e720
Route
ORAL
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Acesulfame Potassium Ammonium Glycyrrhizate Aspartame Carnauba Wax Croscarmellose Sodium Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Mannitol Silicon Dioxide Sodium Lauryl Sulfate Soybean Oil Succinic Acid

Identifiers & Packaging

Pill Appearance
Imprint: L461 Shape: round Color: orange Size: 13 mm Score: 2
Marketing Status
ANDA Active Since 2005-02-12

Description

Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purposes

Pain reliever/fever reducer

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

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.

Directions
  • chew or crush tablets completely before swallowing
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day

Dosing Chart

Weight (lb)

Age (yr)

Tablets

under 24

under 2

ask a doctor

24-35

2-3

1

36-47

4-5

1 ½

48-59

6-8

2

60-71

9-10

2 ½

72-95

11

3

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
Other Information
  • phenylketonurics: contains phenylalanine 6 mg per tablet
  • store between 20-25°C (68-77°F)
  • do not use if printed seal under cap is broken or missing
Inactive Ingredients

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions Or Comments?

1-800-289-8343

Principal Display Panel

Hy•Vee®

Compare To Children’s Motrin® Active Ingredient

For Ages 2 to 11 Years

Orange Flavor

Children’s Ibuprofen

Chewable Tablets 100 mg

Pain Reliever/Fever Reducer (NSAID)

actual size

LASTS UP TO 8 HOURS

• Chewables

Chew or crush tablets completely before swallowing

24 TABLETS

When Using This Product
  • mouth or throat burning may occur; give with food or water
  • take with food or milk if stomach upset occurs
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
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 the 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)

Active Ingredient (in Each Chewable Tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If the Child Is
  • under a doctor’s care for any serious condition
  • taking any other drug

Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purposes

Pain reliever/fever reducer

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

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.

Directions
  • chew or crush tablets completely before swallowing
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day

Dosing Chart

Weight (lb)

Age (yr)

Tablets

under 24

under 2

ask a doctor

24-35

2-3

1

36-47

4-5

1 ½

48-59

6-8

2

60-71

9-10

2 ½

72-95

11

3

Do Not Use (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
Other Information (Other information)
  • phenylketonurics: contains phenylalanine 6 mg per tablet
  • store between 20-25°C (68-77°F)
  • do not use if printed seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions Or Comments? (Questions or comments?)

1-800-289-8343

Principal Display Panel

Hy•Vee®

Compare To Children’s Motrin® Active Ingredient

For Ages 2 to 11 Years

Orange Flavor

Children’s Ibuprofen

Chewable Tablets 100 mg

Pain Reliever/Fever Reducer (NSAID)

actual size

LASTS UP TO 8 HOURS

• Chewables

Chew or crush tablets completely before swallowing

24 TABLETS

When Using This Product (When using this product)
  • mouth or throat burning may occur; give with food or water
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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 the 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. (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)

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
  • under a doctor’s care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)