Hy-Vee, Inc. Children’s Ibuprofen Oral Suspension Drug Facts

ibuprofen by

Drug Labeling and Warnings

ibuprofen by is a Otc medication manufactured, distributed, or labeled by HyVee Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IBUPROFEN CHILDRENS- ibuprofen suspension 
HyVee Inc

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Hy-Vee, Inc. Children’s Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever

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.

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, or kidney disease
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • 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
  • mL = milliliter; tsp = teaspoonful
  • 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 or tsp)**
  •   under 24 lbs
  •   under 2 years
  •   ask a doctor
  •   24-35 lbs
  •   2-3 years
  •   5 mL (1 tsp)
  •   36-47 lbs
  •   4-5 years
  •   7.5 mL (1 ½ tsp)
  •   48-59 lbs
  •   6-8 years
  •   10 mL (2 tsp)
  •   60-71 lbs
  •   9-10 years
  •   12.5 mL (2 ½ tsp)
  •   72-95 lbs
  •   11 years
  •   15 mL (3 tsp)
  •   ** or as directed by a doctor

Other information

  • each 5 mL (1 tsp) 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
  • see bottom panel for lot number and expiration date

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

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the Active Ingredient of Children’s Motrin® Bubble Gum Flavor

For Ages 2 to 11 Years

Children’s

Ibuprofen

Oral Suspension 100 mg per 5 mL

Pain Reliever/Fever Reducer (NSAID)

Bubble Gum Flavor

Lasts up to 8 Hours

Alcohol Free

BONUS SIZE

4 oz + 1 oz FREE

5 FL OZ (148 mL)

HyVee Health Children's Ibuprofen image
IBUPROFEN  CHILDRENS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42507-166
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINK (light) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42507-166-261 in 1 CARTON05/13/200204/18/2019
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 42507-166-281 in 1 CARTON05/13/200205/05/2016
2148 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493705/13/200204/18/2019
Labeler - HyVee Inc (006925671)

Revised: 11/2019
 
HyVee Inc